Stryker Tornier Perform Humeral System, Reversed Insert, 45%, REF DWP2393, for shoulder arthroplasty
FDA device recall Z-3309-2024 · posted 2024-09-27 · Open, Classified
Recall details
- Recalling firm
- Tornier, Inc
- 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.
- Action taken
- 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: memphis.fieldaction@stryker.com.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- PAO
- Quantity affected
- 38 units
- Distribution
- US Nationwide distribution.
- Date initiated
- 2024-08-29
- Date posted
- 2024-09-27
- Location
- Bloomington, MN
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PERFORM Humeral System – Stem (K201315) | Tornier, Inc. | 2020-09-11 |