stryker TORNIER PERFORM HUMERAL SYSTEM - STEMLESS US Anatomic Nucleus, REF DWM003A; anatomic total arthroplasty of the s
FDA device recall Z-3155-2024 · posted 2024-09-16 · Open, Classified
Recall details
- Recalling firm
- Tornier, Inc
- Reason for recall
- One lot of Perform Humeral Nucleus may exceed the specification for bacterial endotoxin load (max 20 EU/device).
- Action taken
- Stryker issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees on 08/29/2024 via mail and email. The notice explained the issue, potential risk, and requested the following actions be taken: identify and isolate all affected product to prevent accidental use, and complete and return the response form. Upon receipt, Stryker will contact the consignee and arrange for the return of the product. Distributor were directed to notify their customers. Stryker issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees on 08/29/2024 via mail and email. The notice explained the issue, potential risk, and requested the following actions be taken: identify and isolate all affected product to prevent accidental use, and complete and return the response form. Upon receipt, Stryker will contact the consignee and arrange for the return of the product. Distributors were directed to notify their customers. For questions or concerns, please contact memphis.fieldaction@stryker.com.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- PKC
- Quantity affected
- 5 units
- Distribution
- US Nationwide distribution in the states of IL, WI, AZ, NV, SD.
- Date initiated
- 2024-08-29
- Date posted
- 2024-09-16
- Location
- Bloomington, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Tornier Perform Humeral System – Stemless (K220418) | Tornier, Inc. | 2022-09-14 |