Tornier Perform Humeral System (Stryker) – Endotoxin Load (2024)

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

One lot of Perform Humeral Nucleus may exceed the specification for bacterial endotoxin load (max 20 EU/device).

Recommended Action

Per FDA guidance

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.