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Open, Classified

stryker Tornier Perform Reversed Augmented Glenoid Lateralized Baseplate, 25mm, Offset +3mm, REF DWJ502

FDA Recall Z-0113-2024 · Posted 2023-10-13

Recalling FirmTornier, Inc
Recall StatusOpen, Classified
Product CodePHX
Date Initiated2023-09-15
Product Quantity30 units

Reason for Recall

One lot of Tournier Perform Reversed Lateralized Baseplates were found to have been manufactured with 6mm spacers instead of 3mm spacers. This nonconformance prevents the central screw from being able to thread into the baseplate.

Firm Action

Stryker issued an URGENT MEDICAL DEVICE RECALL NOTICE to its consignees on 09/15/2023 by email and letter. The letter explained the issue and the risk. Actions requests were: Check inventory, quarantine, and respond to the notice. Distributors were directed to notify all applicable parties. Stryker is requesting the return of the affected product.

Root Cause

Process change control

Distribution Pattern

US: CA, CO, IL, MA, MN, NC, OR, RI, SC, TN

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K161742Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed GlenoidTornier, Inc. · 2016-11-15

Official Source

View FDA Recall →

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

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