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 2 Device Recall Gamma

  • 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 2 Device Recall Gammasee related information
Date Initiated by FirmJanuary 20, 2003
Date PostedFebruary 26, 2003
Recall Status1 Terminated 3 on May 06, 2003
Recall NumberZ-0579-03
Recall Event ID 25585
Product Classification Bit, Drill - Product Code HTW
ProductGamma Drill 5.5x300mm
Code Information 1214-5300S -- Gamma Drill 5.5x300mm --  K400056; K412682; K423453; K451275; K467231; K469197; K494341; K494342; K508650; K516457; K526734; K533284; K542636; K548132; K553788; K553789; K562650; K562654; K573121; K573122; K579936; K579937; K579938; K619518; K622108; K622109; K637404; K641097; K653378; K665203; K665204; K665205; K678519; K679127; K713867; K713868; K714918; K714919; K714920; K714921; K714922; K714923; K714924; K714925; K714926; K717459; K717462; K721328; K724574; K732012; K732013; K733474; K748814; K748817; K753097; K753098; K774660; K775180; K784772; K784774; K784775; K821925; K829527; K829529; K834976; K957002.  
Recalling Firm/
Manufacturer		 Stryker Howmedica Osteonics
300 Commerce Court
Mahwah NJ 07430
For Additional Information ContactThomas Grzeskowiak
201-831-5495
Manufacturer Reason
for Recall		Certain sterile packed drills with center tip may penetrate the foam and blister resulting in loss of sterility.
FDA Determined
Cause 2		Other
ActionHowmedica sent notification letters and product accountability forms to all branches/agents via FedEx with return receipt. To Hospitals, notifications letters were sent to OR Supervisors via FedEx with return receipts.
Quantity in Commerce5062
DistributionProduct was distributed to 53 Howmedica Branches/agents, 996 hospitals, and 63 government hospitals throughout the nation.
Total Product Life CycleTPLC 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.
-
-