Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 3 Device Recall Stryker Orthopaedics Bone Screw

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 3 Device Recall Stryker Orthopaedics Bone Screw see related information
Date Initiated by Firm June 26, 2009
Date Posted September 14, 2009
Recall Status1 Terminated 3 on July 27, 2010
Recall Number Z-2120-2009
Recall Event ID 52713
510(K)Number K873251  
Product Classification Screw, fixation, bone - Product Code HWC
Product Stryker Orthopaedics Cancellous Bone Screw;
Dia 6.5 mm; Lnth: 30 mm; Sterile;
Made in the USA;
Stryker Osteonics Corp.
325 Corporate Drive
Mahwah, NJ 07430.

The bone screws are optional fixtures that may be used during knee and hip replacement procedures.
Code Information Catalog number: 2030-6530-1: 6.5 CANCELLOUS BONE SCREW 30mm VDJMKE 29-Jun-2013 6.5 CANCELLOUS BONE SCREW 30mm W67MKE 29-Jun-2013 6.5 CANCELLOUS BONE SCREW 30mm VDLMKE 30-Jun-2013 6.5 CANCELLOUS BONE SCREW 30mm VDHMKE 30-Jun-2013 6.5 CANCELLOUS BONE SCREW 30mm VDPMKE 30-Jun-2013 6.5 CANCELLOUS BONE SCREW 30mm WM8MKE 01-Jul-2013 6.5 CANCELLOUS BONE SCREW 30mm WDTMKE 01-Jul-2013 6.5 CANCELLOUS BONE SCREW 30mm WDRMKE 01-Jul-2013 6.5 CANCELLOUS BONE SCREW 30mm WDYMKE 01-Jul-2013 6.5 CANCELLOUS BONE SCREW 30mm WDWMKE 01-Jul-2013 6.5 CANCELLOUS BONE SCREW 30mm WDVMKE 02-Jul-2013 6.5 CANCELLOUS BONE SCREW 30mm 043MLE 02-Jul-2013 6.5 CANCELLOUS BONE SCREW 30mm WDXMKE 02-Jul-2013 6.5 CANCELLOUS BONE SCREW 30mm WMAMKE 02-Jul-2013 6.5 CANCELLOUS BONE SCREW 30mm WM9MKE 02-Jul-2013 6.5 CANCELLOUS BONE SCREW 30mm 044MLE 06-Jul-2013 6.5 CANCELLOUS BONE SCREW 30mm WMDMKE 06-Jul-2013 6.5 CANCELLOUS BONE SCREW 30mm 1K7MLE 07-Jul-2013 6.5 CANCELLOUS BONE SCREW 30mm 1KDMLE 07-Jul-2013 6.5 CANCELLOUS BONE SCREW 30mm 1KEMLE 07-Jul-2013 6.5 CANCELLOUS BONE SCREW 30mm WMEMKE 08-Jul-2013 6.5 CANCELLOUS BONE SCREW 30mm 1KHMLE 08-Jul-2013 6.5 CANCELLOUS BONE SCREW 30mm 1KAMLE 08-Jul-2013 6.5 CANCELLOUS BONE SCREW 30mm 6X1MLE 13-Jul-2013 6.5 CANCELLOUS BONE SCREW 30mm 6X3MLE 13-Jul-2013 6.5 CANCELLOUS BONE SCREW 30mm 6WWMLE 14-Jul-2013 6.5 CANCELLOUS BONE SCREW 30mm 6X4MLE 14-Jul-2013 6.5 CANCELLOUS BONE SCREW 30mm 6X5MLE 14-Jul-2013 6.5 CANCELLOUS BONE SCREW 30mm 6WXMLE 14-Jul-2013 6.5 CANCELLOUS BONE SCREW 30mm 6X0MLE 14-Jul-2013 6.5 CANCELLOUS BONE SCREW 30mm 6X6MLE 14-Jul-2013 6.5 CANCELLOUS BONE SCREW 30mm 9DYMLE 15-Jul-2013 6.5 CANCELLOUS BONE SCREW 30mm 9E0MLE 15-Jul-2013 6.5 CANCELLOUS BONE SCREW 30mm 9E4MLE 16-Jul-2013 6.5 CANCELLOUS BONE SCREW 30mm 9E1MLE 16-Jul-2013 6.5 CANCELLOUS BONE SCREW 30mm 9E3MLE 16-Jul-2013 6.5 CANCELLOUS BONE SCREW 30mm 9E6MLE 16-Jul-2013 6.5 CANCELLOUS BONE SCREW 30mm 9E5MLE 16-Jul-2013 6.5 CANCELLOUS BONE SCREW 30mm KJTMLE 23-Jul-2013 6.5 CANCELLOUS BONE SCREW 30mm KL0MLE 23-Jul-2013 6.5 CANCELLOUS BONE SCREW 30mm KL1MLE 23-Jul-2013 6.5 CANCELLOUS BONE SCREW 30mm KL9MLE 23-Jul-2013 6.5 CANCELLOUS BONE SCREW 30mm KLAMLE 23-Jul-2013 6.5 CANCELLOUS BONE SCREW 30mm KLDMLE 23-Jul-2013 6.5 CANCELLOUS BONE SCREW 30mm KLMMLE 25-Jul-2013 6.5 CANCELLOUS BONE SCREW 30mm KLHMLE 25-Jul-2013 6.5 CANCELLOUS BONE SCREW 30mm KLEMLE 25-Jul-2013 6.5 CANCELLOUS BONE SCREW 30mm KLJMLE 25-Jul-2013 6.5 CANCELLOUS BONE SCREW 30mm KLNMLE 25-Jul-2013 6.5 CANCELLOUS BONE SCREW 30mm KLKMLE 25-Jul-2013 6.5 CANCELLOUS BONE SCREW 30mm KLLMLE 25-Jul-2013 6.5 CANCELLOUS BONE SCREW 30mm LW6MLE 25-Jul-2013 6.5 CANCELLOUS BONE SCREW 30mm LWAMLE 25-Jul-2013 6.5 CANCELLOUS BONE SCREW 30mm VDMMKE 11-Sep-2013 6.5 CANCELLOUS BONE SCREW 30mm 1EP16J 06-Nov-2013 6.5 CANCELLOUS BONE SCREW 30mm 1EP16K 06-Nov-2013 6.5 CANCELLOUS BONE SCREW 30mm MEPY9M 06-Nov-2013 6.5 CANCELLOUS BONE SCREW 30mm MEPY9N 06-Nov-2013 6.5 CANCELLOUS BONE SCREW 30mm 1EP16W 06-Nov-2013 6.5 CANCELLOUS BONE SCREW 30mm 1EP03V 06-Nov-2013 6.5 CANCELLOUS BONE SCREW 30mm 1EP16Y 06-Nov-2013 6.5 CANCELLOUS BONE SCREW 30mm 1EP03W 06-Nov-2013 6.5 CANCELLOUS BONE SCREW 30mm 1EP03Y 06-Nov-2013 6.5 CANCELLOUS BONE SCREW 30mm 1EP040 06-Nov-2013 6.5 CANCELLOUS BONE SCREW 30mm MER0VH 06-Nov-2013 6.5 CANCELLOUS BONE SCREW 30mm MER0VJ 06-Nov-2013 6.5 CANCELLOUS BONE SCREW 30mm MER0VM 06-Nov-2013 6.5 CANCELLOUS BONE SCREW 30mm MER0VK 06-Nov-2013 6.5 CANCELLOUS BONE SCREW 30mm MER0VL 06-Nov-2013 6.5 CANCELLOUS BONE SCREW 30mm MER1TM 11-Nov-2013 6.5 CANCELLOUS BONE SCREW 30mm MER1TT 11-Nov-2013 6.5 CANCELLOUS BONE SCREW 30mm MER1V0 11-Nov-2013 6.5 CANCELLOUS BONE SCREW 30mm MEPY9J 11-Nov-2013 6.5 CANCELLOUS BONE SCREW 30mm MEPY9K 11-Nov-2013 6.5 CANCELLOUS BONE SCREW 30mm 1EP03X 12-Nov-2013 6.5 CANCELLOUS BONE SCREW 30mm 1EP171 12-Nov-2013 6.5 CANCELLOUS BONE SCREW 30mm 1EP16X 12-Nov-2013 6.5 CANCELLOUS BONE SCREW 30mm 1EP16T 12-Nov-2013 6.5 CANCELLOUS BONE SCREW 30mm MER0VN 12-Nov-2013 6.5 CANCELLOUS BONE SCREW 30mm MER0VR 12-Nov-2013 6.5 CANCELLOUS BONE SCREW 30mm MER0VP 12-Nov-2013 6.5 CANCELLOUS BONE SCREW 30mm MER0VT 12-Nov-2013 6.5 CANCELLOUS BONE SCREW 30mm MER1TK 12-Nov-2013 6.5 CANCELLOUS BONE SCREW 30mm MER1TP 12-Nov-2013 6.5 CANCELLOUS BONE SCREW 30mm MER1TW 12-Nov-2013 6.5 CANCELLOUS BONE SCREW 30mm MER1V1 12-Nov-2013 6.5 CANCELLOUS BONE SCREW 30mm MER1TY 13-Nov-2013 6.5 CANCELLOUS BONE SCREW 30mm MER0VV 13-Nov-2013 6.5 CANCELLOUS BONE SCREW 30mm MER61W 13-Nov-2013 6.5 CANCELLOUS BONE SCREW 30mm MER629 16-Nov-2013 6.5 CANCELLOUS BONE SCREW 30mm MER62E 16-Nov-2013 6.5 CANCELLOUS BONE SCREW 30mm MER71V 16-Nov-2013 6.5 CANCELLOUS BONE SCREW 30mm MER71X 16-Nov-2013 6.5 CANCELLOUS BONE SCREW 30mm MER8AP 16-Nov-2013 6.5 CANCELLOUS BONE SCREW 30mm MER8AW 16-Nov-2013 6.5 CANCELLOUS BONE SCREW 30mm MER8AR 16-Nov-2013 6.5 CANCELLOUS BONE SCREW 30mm MER8AV 16-Nov-2013 6.5 CANCELLOUS BONE SCREW 30mm MER8AY 16-Nov-2013 6.5 CANCELLOUS BONE SCREW 30mm MER620 18-Nov-2013 6.5 CANCELLOUS BONE SCREW 30mm MER62L 18-Nov-2013 6.5 CANCELLOUS BONE SCREW 30mm MER622 18-Nov-2013 6.5 CANCELLOUS BONE SCREW 30mm MER62A 18-Nov-2013 6.5 CANCELLOUS BONE SCREW 30mm MER62K 18-Nov-2013 6.5 CANCELLOUS BONE SCREW 30mm MER621 18-Nov-2013 6.5 CANCELLOUS BONE SCREW 30mm MER71Y 18-Nov-2013 6.5 CANCELLOUS BONE SCREW 30mm MER627 18-Nov-2013 6.5 CANCELLOUS BONE SCREW 30mm MER626 18-Nov-2013 6.5 CANCELLOUS BONE SCREW 30mm MER623 18-Nov-2013 6.5 CANCELLOUS BONE SCREW 30mm MER62D 18-Nov-2013 6.5 CANCELLOUS BONE SCREW 30mm MER625 18-Nov-2013 6.5 CANCELLOUS BONE SCREW 30mm MER62J 18-Nov-2013 6.5 CANCELLOUS BONE SCREW 30mm MER8AX 19-Nov-2013 6.5 CANCELLOUS BONE SCREW 30mm MER8D1 19-Nov-2013 6.5 CANCELLOUS BONE SCREW 30mm MER8D2 19-Nov-2013 6.5 CANCELLOUS BONE SCREW 30mm MER99X 19-Nov-2013 6.5 CANCELLOUS BONE SCREW 30mm MER99Y 19-Nov-2013 6.5 CANCELLOUS BONE SCREW 30mm MER99V 19-Nov-2013 6.5 CANCELLOUS BONE SCREW 30mm MERD38 19-Nov-2013 6.5 CANCELLOUS BONE SCREW 30mm MER8AT 20-Nov-2013 6.5 CANCELLOUS BONE SCREW 30mm MER8D0 20-Nov-2013 6.5 CANCELLOUS BONE SCREW 30mm MER99R 20-Nov-2013 6.5 CANCELLOUS BONE SCREW 30mm MER9A0 20-Nov-2013 6.5 CANCELLOUS BONE SCREW 30mm MERD3L 20-Nov-2013 6.5 CANCELLOUS BONE SCREW 30mm MERD49 20-Nov-2013 6.5 CANCELLOUS BONE SCREW 30mm MERD3T 20-Nov-2013 6.5 CANCELLOUS BONE SCREW 30mm MER99T 23-Nov-2013 6.5 CANCELLOUS BONE SCREW 30mm MERD3A 23-Nov-2013 6.5 CANCELLOUS BONE SCREW 30mm MERD4H 23-Nov-2013 6.5 CANCELLOUS BONE SCREW 30mm MERD3E 23-Nov-2013 6.5 CANCELLOUS BONE SCREW 30mm MEREN4 23-Nov-2013 6.5 CANCELLOUS BONE SCREW 30mm MEREN6 23-Nov-2013 6.5 CANCELLOUS BONE SCREW 30mm MEREN7 23-Nov-2013 6.5 CANCELLOUS BONE SCREW 30mm MEREN8 23-Nov-2013 6.5 CANCELLOUS BONE SCREW 30mm MEREN9 23-Nov-2013 6.5 CANCELLOUS BONE SCREW 30mm MEREN2 23-Nov-2013 6.5 CANCELLOUS BONE SCREW 30mm MERD3N 23-Nov-2013 6.5 CANCELLOUS BONE SCREW 30mm MEREN5 23-Nov-2013 6.5 CANCELLOUS BONE SCREW 30mm MERJ5P 23-Nov-2013 6.5 CANCELLOUS BONE SCREW 30mm MERJJ8 23-Nov-2013 6.5 CANCELLOUS BONE SCREW 30mm MERJ82 23-Nov-2013 6.5 CANCELLOUS BONE SCREW 30mm MERJ7H 23-Nov-2013 6.5 CANCELLOUS BONE SCREW 30mm MEREN3 04-Dec-2013 6.5 CANCELLOUS BONE SCREW 30mm MERHVT 04-Dec-2013 6.5 CANCELLOUS BONE SCREW 30mm MET3H7 14-Dec-2013 6.5 CANCELLOUS BONE SCREW 30mm MET3HA 14-Dec-2013 6.5 CANCELLOUS BONE SCREW 30mm MET3H6 18-Dec-2013 6.5 CANCELLOUS BONE SCREW 30mm MET3HK 18-Dec-2013 6.5 CANCELLOUS BONE SCREW 30mm META6M 18-Dec-2013 6.5 CANCELLOUS BONE SCREW 30mm MET3HE 22-Dec-2013 6.5 CANCELLOUS BONE SCREW 30mm MET3H9 22-Dec-2013 6.5 CANCELLOUS BONE SCREW 30mm MET3HL 22-Dec-2013 6.5 CANCELLOUS BONE SCREW 30mm MET3HH 22-Dec-2013 6.5 CANCELLOUS BONE SCREW 30mm MET3H8 30-Dec-2013 6.5 CANCELLOUS BONE SCREW 30mm MET3HD 30-Dec-2013 6.5 CANCELLOUS BONE SCREW 30mm METM1V 04-Jan-2014 6.5 CANCELLOUS BONE SCREW 30mm METM1X 04-Jan-2014 6.5 CANCELLOUS BONE SCREW 30mm METM1W 04-Jan-2014 6.5 CANCELLOUS BONE SCREW 30mm METM1Y 04-Jan-2014 6.5 CANCELLOUS BONE SCREW 30mm METM20 04-Jan-2014 6.5 CANCELLOUS BONE SCREW 30mm METM21 04-Jan-2014 6.5 CANCELLOUS BONE SCREW 30mm METM24 04-Jan-2014 6.5 CANCELLOUS BONE SCREW 30mm METM22 04-Jan-2014 6.5 CANCELLOUS BONE SCREW 30mm METM25 04-Jan-2014 6.5 CANCELLOUS BONE SCREW 30mm METN2J 04-Jan-2014 6.5 CANCELLOUS BONE SCREW 30mm METM23 07-Jan-2014 6.5 CANCELLOUS BONE SCREW 30mm METNV9 07-Jan-2014 6.5 CANCELLOUS BONE SCREW 30mm AH8MKE 16-Jun-2013 6.5 CANCELLOUS BONE SCREW 30mm AH9MKE 16-Jun-2013 6.5 CANCELLOUS BONE SCREW 30mm AHDMKE 17-Jun-2013 6.5 CANCELLOUS BONE SCREW 30mm EETMKE 17-Jun-2013 6.5 CANCELLOUS BONE SCREW 30mm EEWMKE 18-Jun-2013 6.5 CANCELLOUS BONE SCREW 30mm EAAMKE 18-Jun-2013 6.5 CANCELLOUS BONE SCREW 30mm EERMKE 18-Jun-2013 6.5 CANCELLOUS BONE SCREW 30mm EEMMKE 18-Jun-2013 6.5 CANCELLOUS BONE SCREW 30mm EEVMKE 18-Jun-2013 6.5 CANCELLOUS BONE SCREW 30mm EENMKE 18-Jun-2013 6.5 CANCELLOUS BONE SCREW 30mm EEPMKE 21-Jun-2013 6.5 CANCELLOUS BONE SCREW 30mm JE8MKE 21-Jun-2013 6.5 CANCELLOUS BONE SCREW 30mm JE9MKE 21-Jun-2013 6.5 CANCELLOUS BONE SCREW 30mm JEDMKE 21-Jun-2013 6.5 CANCELLOUS BONE SCREW 30mm KAEMKE 21-Jun-2013 6.5 CANCELLOUS BONE SCREW 30mm JDYMKE 21-Jun-2013 6.5 CANCELLOUS BONE SCREW 30mm JEAMKE 21-Jun-2013 6.5 CANCELLOUS BONE SCREW 30mm JEEMKE 22-Jun-2013 6.5 CANCELLOUS BONE SCREW 30mm KAWMKE 22-Jun-2013 6.5 CANCELLOUS BONE SCREW 30mm KAXMKE 22-Jun-2013 6.5 CANCELLOUS BONE SCREW 30mm KD0MKE 22-Jun-2013 6.5 CANCELLOUS BONE SCREW 30mm KD2MKE 22-Jun-2013 6.5 CANCELLOUS BONE SCREW 30mm KAJMKE 22-Jun-2013 6.5 CANCELLOUS BONE SCREW 30mm KD1MKE 22-Jun-2013 6.5 CANCELLOUS BONE SCREW 30mm LRXMKE 22-Jun-2013 6.5 CANCELLOUS BONE SCREW 30mm LL6MKE 22-Jun-2013 6.5 CANCELLOUS BONE SCREW 30mm LR9MKE 22-Jun-2013 6.5 CANCELLOUS BONE SCREW 30mm LR5MKE 22-Jun-2013 6.5 CANCELLOUS BONE SCREW 30mm KAHMKE 23-Jun-2013 6.5 CANCELLOUS BONE SCREW 30mm KD3MKE 23-Jun-2013 6.5 CANCELLOUS BONE SCREW 30mm LK0MKE 23-Jun-2013 6.5 CANCELLOUS BONE SCREW 30mm KD5MKE 23-Jun-2013 6.5 CANCELLOUS BONE SCREW 30mm LR6MKE 23-Jun-2013 6.5 CANCELLOUS BONE SCREW 30mm LRNMKE 23-Jun-2013 6.5 CANCELLOUS BONE SCREW 30mm LT5MKE 23-Jun-2013 6.5 CANCELLOUS BONE SCREW 30mm LT1MKE 23-Jun-2013 6.5 CANCELLOUS BONE SCREW 30mm MJ6MKE 23-Jun-2013 6.5 CANCELLOUS BONE SCREW 30mm LRJMKE 23-Jun-2013 6.5 CANCELLOUS BONE SCREW 30mm LR0MKE 24-Jun-2013 6.5 CANCELLOUS BONE SCREW 30mm MKNMKE 24-Jun-2013 6.5 CANCELLOUS BONE SCREW 30mm MKPMKE 24-Jun-2013 6.5 CANCELLOUS BONE SCREW 30mm MJ7MKE 24-Jun-2013 6.5 CANCELLOUS BONE SCREW 30mm MJ8MKE 24-Jun-2013 6.5 CANCELLOUS BONE SCREW 30mm MJAMKE 24-Jun-2013 6.5 CANCELLOUS BONE SCREW 30mm MJ9MKE 24-Jun-2013 6.5 CANCELLOUS BONE SCREW 30mm MJEMKE 24-Jun-2013 6.5 CANCELLOUS BONE SCREW 30mm MJDMKE 24-Jun-2013 6.5 CANCELLOUS BONE SCREW 30mm MJHMKE 25-Jun-2013 6.5 CANCELLOUS BONE SCREW 30mm LWDMLE 25-Jul-2013 6.5 CANCELLOUS BONE SCREW 30mm LW8MLE 25-Jul-2013 6.5 CANCELLOUS BONE SCREW 30mm LW9MLE 28-Jul-2013 6.5 CANCELLOUS BONE SCREW 30mm E9XMME 19-Aug-2013 6.5 CANCELLOUS BONE SCREW 30mm EA0MME 20-Aug-2013 6.5 CANCELLOUS BONE SCREW 30mm EM6MME 20-Aug-2013 6.5 CANCELLOUS BONE SCREW 30mm EM7MME 20-Aug-2013 6.5 CANCELLOUS BONE SCREW 30mm EK6MME 22-Aug-2013 6.5 CANCELLOUS BONE SCREW 30mm EK5MME 22-Aug-2013 6.5 CANCELLOUS BONE SCREW 30mm EK4MME 22-Aug-2013 6.5 CANCELLOUS BONE SCREW 30mm E9YMME 22-Aug-2013 6.5 CANCELLOUS BONE SCREW 30mm EK3MME 22-Aug-2013 6.5 CANCELLOUS BONE SCREW 30mm EK0MME 22-Aug-2013 6.5 CANCELLOUS BONE SCREW 30mm EM9MME 22-Aug-2013 6.5 CANCELLOUS BONE SCREW 30mm EM8MME 22-Aug-2013 6.5 CANCELLOUS BONE SCREW 30mm LVYMME 24-Aug-2013 6.5 CANCELLOUS BONE SCREW 30mm LXAMME 24-Aug-2013 6.5 CANCELLOUS BONE SCREW 30mm LX7MME 25-Aug-2013 6.5 CANCELLOUS BONE SCREW 30mm LXDMME 25-Aug-2013 6.5 CANCELLOUS BONE SCREW 30mm LXJMME 25-Aug-2013 6.5 CANCELLOUS BONE SCREW 30mm N7AMME 25-Aug-2013 6.5 CANCELLOUS BONE SCREW 30mm LXHMME 25-Aug-2013 6.5 CANCELLOUS BONE SCREW 30mm LW1MME 25-Aug-2013 6.5 CANCELLOUS BONE SCREW 30mm LX5MME 27-Aug-2013 6.5 CANCELLOUS BONE SCREW 30mm LX4MME 27-Aug-2013 6.5 CANCELLOUS BONE SCREW 30mm LX6MME 27-Aug-2013 6.5 CANCELLOUS BONE SCREW 30mm LX3MME 27-Aug-2013 6.5 CANCELLOUS BONE SCREW 30mm LXEMME 27-Aug-2013 6.5 CANCELLOUS BONE SCREW 30mm LX9MME 27-Aug-2013 6.5 CANCELLOUS BONE SCREW 30mm LX8MME 27-Aug-2013 6.5 CANCELLOUS BONE SCREW 30mm N7EMME 27-Aug-2013 6.5 CANCELLOUS BONE SCREW 30mm NL1MME 27-Aug-2013 6.5 CANCELLOUS BONE SCREW 30mm NL0MME 27-Aug-2013 6.5 CANCELLOUS BONE SCREW 30mm NL2MME 28-Aug-2013 6.5 CANCELLOUS BONE SCREW 30mm NKYMME 28-Aug-2013 6.5 CANCELLOUS BONE SCREW 30mm 2AAMNE 09-Sep-2013 6.5 CANCELLOUS BONE SCREW 30mm 2ADMNE 09-Sep-2013 6.5 CANCELLOUS BONE SCREW 30mm 2AEMNE 09-Sep-2013 6.5 CANCELLOUS BONE SCREW 30mm 2D7MNE 09-Sep-2013 6.5 CANCELLOUS BONE SCREW 30mm 2AJMNE 09-Sep-2013 6.5 CANCELLOUS BONE SCREW 30mm 2AHMNE 09-Sep-2013 6.5 CANCELLOUS BONE SCREW 30mm 4M3MNE 09-Sep-2013 6.5 CANCELLOUS BONE SCREW 30mm 2A8MNE 10-Sep-2013 6.5 CANCELLOUS BONE SCREW 30mm 2A7MNE 10-Sep-2013 6.5 CANCELLOUS BONE SCREW 30mm 2AKMNE 10-Sep-2013 6.5 CANCELLOUS BONE SCREW 30mm 2A9MNE 10-Sep-2013 6.5 CANCELLOUS BONE SCREW 30mm 4RTMNE 11-Sep-2013 6.5 CANCELLOUS BONE SCREW 30mm 4L8MNE 11-Sep-2013 6.5 CANCELLOUS BONE SCREW 30mm 4M6MNE 11-Sep-2013 6.5 CANCELLOUS BONE SCREW 30mm 4M4MNE 11-Sep-2013 6.5 CANCELLOUS BONE SCREW 30mm 4M2MNE 11-Sep-2013 6.5 CANCELLOUS BONE SCREW 30mm 4M8MNE 16-Sep-2013 6.5 CANCELLOUS BONE SCREW 30mm 7H1MNE 16-Sep-2013 6.5 CANCELLOUS BONE SCREW 30mm 8NXMNE 16-Sep-2013 6.5 CANCELLOUS BONE SCREW 30mm 7H4MNE 17-Sep-2013 6.5 CANCELLOUS BONE SCREW 30mm 8NWMNE 17-Sep-2013 6.5 CANCELLOUS BONE SCREW 30mm 9TWMNE 17-Sep-2013 6.5 CANCELLOUS BONE SCREW 30mm 7H2MNE 21-Sep-2013 6.5 CANCELLOUS BONE SCREW 30mm 7H3MNE 21-Sep-2013 6.5 CANCELLOUS BONE SCREW 30mm 8NVMNE 21-Sep-2013 6.5 CANCELLOUS BONE SCREW 30mm 9TVMNE 21-Sep-2013 6.5 CANCELLOUS BONE SCREW 30mm 9V0MNE 21-Sep-2013 6.5 CANCELLOUS BONE SCREW 30mm 9TYMNE 21-Sep-2013 6.5 CANCELLOUS BONE SCREW 30mm 7H5MNE 25-Sep-2013 6.5 CANCELLOUS BONE SCREW 30mm METN2H 07-Jan-2014 6.5 CANCELLOUS BONE SCREW 30mm METN2D 07-Jan-2014 6.5 CANCELLOUS BONE SCREW 30mm METN2K 07-Jan-2014 6.5 CANCELLOUS BONE SCREW 30mm METN2M 07-Jan-2014 6.5 CANCELLOUS BONE SCREW 30mm METN2N 07-Jan-2014 6.5 CANCELLOUS BONE SCREW 30mm METN2R 07-Jan-2014 6.5 CANCELLOUS BONE SCREW 30mm METNV6 07-Jan-2014 6.5 CANCELLOUS BONE SCREW 30mm METNW3 07-Jan-2014 6.5 CANCELLOUS BONE SCREW 30mm METNW4 07-Jan-2014 6.5 CANCELLOUS BONE SCREW 30mm METNW2 07-Jan-2014 6.5 CANCELLOUS BONE SCREW 30mm METNW1 07-Jan-2014 6.5 CANCELLOUS BONE SCREW 30mm METNW0 07-Jan-2014 6.5 CANCELLOUS BONE SCREW 30mm METNV7 07-Jan-2014 6.5 CANCELLOUS BONE SCREW 30mm METNV8 07-Jan-2014 6.5 CANCELLOUS BONE SCREW 30mm METNW5 07-Jan-2014 6.5 CANCELLOUS BONE SCREW 30mm METNVY 11-Jan-2014 6.5 CANCELLOUS BONE SCREW 30mm MHA125 11-Jan-2014 6.5 CANCELLOUS BONE SCREW 30mm MHA120 11-Jan-2014 6.5 CANCELLOUS BONE SCREW 30mm MHA11Y 11-Jan-2014 6.5 CANCELLOUS BONE SCREW 30mm MHA124 11-Jan-2014 6.5 CANCELLOUS BONE SCREW 30mm MHA11R 11-Jan-2014 6.5 CANCELLOUS BONE SCREW 30mm MHA121 11-Jan-2014 6.5 CANCELLOUS BONE SCREW 30mm MHA123 11-Jan-2014 6.5 CANCELLOUS BONE SCREW 30mm MHA1V4 11-Jan-2014 6.5 CANCELLOUS BONE SCREW 30mm MHA1V2 11-Jan-2014 6.5 CANCELLOUS BONE SCREW 30mm MHA1V3 11-Jan-2014 6.5 CANCELLOUS BONE SCREW 30mm MHA250 11-Jan-2014 6.5 CANCELLOUS BONE SCREW 30mm MHA24Y 11-Jan-2014 6.5 CANCELLOUS BONE SCREW 30mm MHA2A4 11-Jan-2014 6.5 CANCELLOUS BONE SCREW 30mm MHA2P1 11-Jan-2014 6.5 CANCELLOUS BONE SCREW 30mm MHA39M 11-Jan-2014 6.5 CANCELLOUS BONE SCREW 30mm MHA2P2 11-Jan-2014 6.5 CANCELLOUS BONE SCREW 30mm MHA251 11-Jan-2014 6.5 CANCELLOUS BONE SCREW 30mm MHA255 11-Jan-2014 6.5 CANCELLOUS BONE SCREW 30mm MHA253 11-Jan-2014 6.5 CANCELLOUS BONE SCREW 30mm MHA2A3 11-Jan-2014 6.5 CANCELLOUS BONE SCREW 30mm MHA2A5 11-Jan-2014 6.5 CANCELLOUS BONE SCREW 30mm MHA2AA 11-Jan-2014 6.5 CANCELLOUS BONE SCREW 30mm MHA2A7 11-Jan-2014 6.5 CANCELLOUS BONE SCREW 30mm MHA2A8 11-Jan-2014 6.5 CANCELLOUS BONE SCREW 30mm MHA2A9 11-Jan-2014 6.5 CANCELLOUS BONE SCREW 30mm MHA2A6 11-Jan-2014 6.5 CANCELLOUS BONE SCREW 30mm MHA2AE 11-Jan-2014 6.5 CANCELLOUS BONE SCREW 30mm MHA35H 11-Jan-2014 6.5 CANCELLOUS BONE SCREW 30mm MHA2AD 11-Jan-2014 6.5 CANCELLOUS BONE SCREW 30mm MHA39P 11-Jan-2014 6.5 CANCELLOUS BONE SCREW 30mm MHA39R 11-Jan-2014 6.5 CANCELLOUS BONE SCREW 30mm MHA3DT 11-Jan-2014 6.5 CANCELLOUS BONE SCREW 30mm MHA3DR 14-Jan-2014 
Recalling Firm/
Manufacturer		 Stryker Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah NJ 07430
For Additional Information Contact Colleen O'Meara
201-972-2100
Manufacturer Reason
for Recall		 Raw material supplied by a third party used to manufacture various medical devices does not comply with metallurgical requirements outlines in ASTM standard for titanium surgical implants.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Stryker Orthopaedics issued "Urgent Product Recall" letters via Federal Express priority overnight beginning June 26, 2009 to Branches, Hospital Risk Management and Chief of Orthopaedics and Surgeons. All users are requested to examine their inventory, retrieve all affected product and return for reconciliation to Stryker Orthopaedics. Users are also requested to complete the enclosed Product Accountability Form and fax with necessary information to the firm at 1-201-831-6069. For further information, contact Stryker Orthopaedics at 1-201-831-5970.
Quantity in Commerce 51,113 total - all sizes
Distribution Worldwide Distribution
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HWC and Original Applicant = OSTEONICS CORP.
-
-