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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = HRS
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