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Open, Classified

Stryker Tornier Perform Humeral System, Reversed Insert, 45%, REF DWP2393, for shoulder arthroplasty

FDA Recall Z-3309-2024 · Posted 2024-09-27

Recalling FirmTornier, Inc
Recall StatusOpen, Classified
Product CodePAO
Date Initiated2024-08-29
Product Quantity38 units

Reason for Recall

Devices from one lot of Perform" Reversed Inserts may contain a locking ring that was assembled upside down which would prevent the humeral insert from securely seating in the stem or spacer.

Firm Action

Stryker issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees on 08/29/2024 via email. The notice explained the issue, potential risk, and requested the following actions be taken: Identify and isolate the affected units, and respond to the notice via email. Upon receipt of the response, Stryker will arrange for the return of the device. Those consignees who further distributed the product (to other sites or customers) were directed to notify those parties. For questions or concerns, contact: [email protected].

Root Cause

Under Investigation by firm

Distribution Pattern

US Nationwide distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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