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U.S. Department of Health and Human Services

Class 2 Device Recall STRYKER WEDGE INTERFERENCE SCREW SYSTEM, ACL Interface Screw

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 Class 2 Device Recall STRYKER WEDGE INTERFERENCE SCREW SYSTEM, ACL Interface Screwsee related information
Date Initiated by FirmNovember 17, 2017
Create DateMarch 02, 2018
Recall Status1 Terminated 3 on January 29, 2024
Recall NumberZ-0837-2018
Recall Event ID 78668
510(K)NumberK972233 
Product Classification Screw, fixation, bone - Product Code HWC
ProductSTRYKER WEDGE INTERFERENCE SCREW SYSTEM, ACL Interface Screw, 9MM X 25MM, Model 0234010056, labeled sterile.
Code Information Model 0234010056, UDI 04546540754561, Lot No. 17278AG2
Recalling Firm/
Manufacturer		 Stryker Corporation
5900 Optical Ct
San Jose CA 95138-1400
Manufacturer Reason
for Recall		Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn about 11/17/2017 letters were sent by certified mail with tracking information to all domestic accounts and International Stryker sites were notified by email. Instructions include to inform individuals who need to be aware of the device recall, examine all stock areas and/or operating room storage for affected product quarantine and discontinue use of the recalled devices, complete the acknowledgement form, and if affected product is found contact Stryker customer service at 1-800-624-4422 (Option 3) or email endocustomersupport@stryker.com to arrange for product return.
Quantity in Commerce60,753 units total
DistributionDistributed domestically to . Distributed internationally to Australia and Mexico.
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.
510(K) Database510(K)s with Product Code = HWC
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