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U.S. Department of Health and Human Services

Class 2 Device Recall ORTHOLOC

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  Class 2 Device Recall ORTHOLOC see related information
Date Initiated by Firm February 15, 2022
Create Date March 15, 2022
Recall Status1 Terminated 3 on October 05, 2022
Recall Number Z-0786-2022
Recall Event ID 89507
510(K)Number K090692  
Product Classification Plate, fixation, bone - Product Code HRS
Product Wright Medical Technology, Inc. ORTHOLOC Non-Locking Screw 2mm x 8mm, REF 5201120008, non-sterile, a component of the ORTHOLOC 2.0/2.4 Plate System.
Code Information Lot #73967511638696
Recalling Firm/
Manufacturer
Wright Medical Technology, Inc.
1023 Cherry Rd
Memphis TN 38117-5423
For Additional Information Contact Ms. Meghan Wells
901-201-9298
Manufacturer Reason
for Recall
An incorrect screw is packaged in the product, which contains a locking screw instead of a non-locking screw.
FDA Determined
Cause 2
Process control
Action The firm notified the foreign competent authority via email on 2/15/2021 which included a copy of the recall letter. Once the foreign competent authority approves the recall, the recall letter will be sent to the foreign consignee. The recall letter is dated 2/15/2022 and describes the product, the issue, potential risks, and the actions needed. The actions included (1) informing individuals within their organization who need to be aware of this device recall; (2) immediately check all stock areas and/or operating room storage to determine if there is any affected product; (3) quarantine and discontinue use of the recalled device; (4) complete the business reply form and a Stryker representative will contact the customer to arrange for return and replacement of the device; (5) inform Stryker if the device has been distributed to other organizations. If so, provide contact details so that Stryker can inform the recipient appropriately. If the consignee is a distributor, they are responsible for notifying the affected customers; and (6) inform Stryker of any adverse events concerning the use of the device.
Quantity in Commerce 1 package
Distribution International distribution to the country of France.
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 = HRS and Original Applicant = WRIGHT MEDICAL TECHNOLOGY, INC.
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