Recall Z-3155-2024 · PKC Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained
Tornier, Inc
stryker TORNIER PERFORM HUMERAL SYSTEM - STEMLESS US Anatomic Nucleus, REF DWM003A; anatomic total arthroplasty of the shoulder
| Date | Sep 16, 2024 (initiated Aug 29, 2024) |
| Status | Open, Classified |
| Reason | One lot of Perform Humeral Nucleus may exceed the specification for bacterial endotoxin load (max 20 EU/device). |
| Root cause | Under Investigation by firm |
| Action | 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 i |
| Quantity | 5 units |
| Distribution | US Nationwide distribution in the states of IL, WI, AZ, NV, SD. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K220418 | Tornier Perform Humeral System Stemless Tornier, Inc., Sep 14, 2022 |