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U.S. Department of Health and Human Services

Class 2 Device Recall Trauma Large Screws

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  Class 2 Device Recall Trauma Large Screws see related information
Date Initiated by Firm July 22, 2014
Date Posted August 26, 2014
Recall Status1 Terminated 3 on September 15, 2015
Recall Number Z-2549-2014
Recall Event ID 68818
510(K)Number K111447  
Product Classification Screw, fixation, bone - Product Code HWC
Product Trauma Large Screws:
CANN BONE SCREW 7.0MMX100MMLG
CANN BONE SCREW 7.0X105LG
CANN BONE SCREW 7.0X105LG
CANN BONE SCREW 7.0MMX105MMLG
CANN BONE SCREW 7.0X110LG
CANN BONE SCREW 7.0X110LG
CANN BONE SCREW 7.0MMX110MMLG
CANN BONE SCREW 7.0X115LG
CANN BONE SCREW 7.0X115LG
CANN BONE SCREW 7.0MMX115MMLG
CANN BONE SCREW 7.0X120LG
CANN BONE SCREW 7.0X120LG
CANN BONE SCREW 7.0MMX120MMLG
CANN BONE SCREW 7.0X125LG
CANN BONE SCREW 7.0MMX125MMLG
CANN BONE SCREW 7.0X130LG
CANN BONE SCREW 7.0MMX130MMLG
RECON SCR LGE 5.5MMDX105MM
RECON SCR LGE 5.5MMDX110MM
RECON SCR LGE 5.5MMDX115MM
RECON SCR LGE 5.5MMDX120MM
RECON SCR LGE 5.5MMDX125MM
RECON SCR LGE 5.5MMDX130MM
ITST ANTI-ROT SCR 6.5MMDX105MM
ITST ANTI-ROT SCR 6.5MMDX110MM
PERI. SCR 3.5MM X105MML
PERI SCR. 6.5MM X 100MM L
PERI SCR. 6.5MM X 140MM L
PERI SCR. 6.5MM X 100MM L
PERI SCR. 6.5MM X 100MM L
3.5MM CORT SCR X 105MM SELFTAP
3.5MM CORT SCR X 110MM SELFTAP
5.5MM X 100MM CANN LKNG SCREW
Z NAIL 6.0 X 105 CANC SCREW PT
Z NAIL 6.0 X 110 CANC SCREW PT
Z NAIL 6.0 X 115 CANC SCREW PT
Z NAIL 6.0 X 120 CANC SCREW PT
Z NAIL 6.0 X 125 CANC SCREW PT
Z NAIL 6.0 X 130 CANC SCREW PT
Z NAIL 6.0 X 135 CANC SCREW PT
Z NAIL 6.0 X 140 CANC SCREW PT
Z NAIL 6.0 X 105 CANC SCREW FA
Z NAIL 6.0 X 110 CANC SCREW FA
Z NAIL 6.0 X 115 CANC SCREW FA
Z NAIL 6.0 X 120 CANC SCREW FA
Z NAIL 6.0 X 125 CANC SCREW FA
Z NAIL 6.0 X 130 CANC SCREW FA
Z NAIL 6.0 X 135 CANC SCREW FA
Z NAIL 6.0 X 140 CANC SCREW FA
Z NAIL 6.0 X 105 CANC SCREW PT
Z NAIL 6.0 X 110 CANC SCREW PT
Z NAIL 6.0 X 115 CANC SCREW PT
Z NAIL 6.0 X 120 CANC SCREW PT
Z NAIL 6.0 X 125 CANC SCREW PT
Z NAIL 6.0 X 130 CANC SCREW PT
Z NAIL 6.0 X 135 CANC SCREW PT
Z NAIL 6.0 X 140 CANC SCREW PT
Z NAIL 6.0 X 105 CANC SCREW FA
Z NAIL 6.0 X 110 CANC SCREW FA
Z NAIL 6.0 X 115CANC SCREW FA
Z NAIL 6.0 X 120CANC SCREW FA
Z NAIL 6.0 X 125 CANC SCREW FA
Z NAIL 6.0 X 130 CANC SCREW FA
Z NAIL 6.0 X 135 CANC SCREW FA
Z NAIL 6.0 X 140 CANC SCREW FA
3.5X105 CORT SCR
3.5 X 105 CORT SCR SELF TAP
3.5X110 CORT SCR
3.5 X 110 CORT SCR SELF TAP
3.5X115 CORT SCR
3.5 X 115 CORT SCR SELF TAP
3.5X120 CORT SCR
3.5 X 120 CORT SCR SELF TAP
3.5X125 CORT SCR
3.5X130 CORT SCR
3.5X135 CORT SCR
3.5X140 CORT SCR
3.5X145 CORT SCR
3.5X150 CORT SCR
4.5 X 105 CORT SCR SELF TAP
4.5 X 110 CORT SCR SELF TAP
4.5 X 120 CORT SCR SELF TAP
6.5X105 CANC SCR, FULLY THDED
6.5X105 CANC SCR, 16MM THD
6.5X105 CANC SCR, 32MM THD
6.5X110 CANC SCR, FULLY THDED
6.5X110 CANC SCR, 16MM THD
6.5X110 CANC SCR, 32MM THD
6.5X115 CANC SCR, 32MM THD
6.5X120 CANC SCR, 32MM THD
Code Information Item Numbers 00114610099, 00114610500, 00114610532, 00114610599, 00114611000, 00114611032, 00114611099, 00114611500, 00114611532, 00114611599, 00114612000, 00114612032, 00114612099, 00114612500, 00114612599, 00114613000, 00114613099, 00225210555, 00225211055, 00225211555, 00225212055, 00225212555, 00225213055, 00225710565, 00225711065, 47234712005, 47234712400, 47234712440, 47234712500, 47234712600, 47234810535, 47234811035, 47235910055, 47248310560, 47248311060, 47248311560, 47248312060, 47248312560, 47248313060, 47248313560, 47248314060, 47248410560, 47248411060, 47248411560, 47248412060, 47248412560, 47248413060, 47248413560, 47248414060, 47348310560, 47348311060, 47348311560, 47348312060, 47348312560, 47348313060, 47348313560, 47348314060, 47348410560, 47348411060, 47348411560, 47348412060, 47348412560, 47348413060, 47348413560, 47348414060, 47483510500, 47483510501, 47483511000, 47483511001, 47483511500, 47483511501, 47483512000, 47483512001, 47483512500, 47483513000, 47483513500, 47483514000, 47483514500, 47483515000, 47484510501, 47484511001, 47484512001, 47486510500, 47486510501, 47486510502, 47486511000, 47486511001, 47486511002, 47486511502, 47486512002 EXPIRATION DATE PRIOR TO 2024-07
Recalling Firm/
Manufacturer		 Zimmer, Inc.
1800 W Center St
Warsaw IN 46580-2304
For Additional Information Contact
800-613-6131
Manufacturer Reason
for Recall		 Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configurations due to packaging design verification test failures. Specifically, multiple test samples from each of the six configurations failed simulated distribution and shipping testing when the devices either breached inner or outer package trays or seal integrity was lost.
FDA Determined
Cause 2		 Package design/selection
Action Zimmer sent an URGENT MEDICAL DEVICE RECALL letter dated July 2014 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Please call the Customer Call Center at 1-800-348-2759 for questions or concerns involving this notice.
Quantity in Commerce 972,125 units
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 = ZIMMER INC.
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