—#191795

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.

FDA product code: HRS — Plate, Fixation, Bone
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K090692
Affected lot / code info: Lot #73967511638696

Why it was recalled

An incorrect screw is packaged in the product, which contains a locking screw instead of a non-locking screw.

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Wright Medical Technology, Inc.
Address: 1023 Cherry Rd, Memphis, Tennessee 38117-5423

Distribution

Distribution pattern: International distribution to the country of France.

Timeline

Recall initiated: 2022-02-15
Terminated: 2022-10-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #191795. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.