Recall Z-1234-2023— Stryker Leibinger GmbH & Co. KG
Class II · Ongoing
Class II FDA medical device recall by Stryker Leibinger GmbH & Co. KG, initiated 2022-12-06. FDA's recall record names no specific 510(k) clearance for this event. Product: Patient-Fitted Temporomandibular (TMJ) Reconstruction Prosthesis. Reason: Device was shipped without having regulatory approval..
- Recalling firm
- Stryker Leibinger GmbH & Co. KG
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-12-06
- Firm location
- Freiburg Im Breisgau, Germany
Product description
Patient-Fitted Temporomandibular (TMJ) Reconstruction Prosthesis
Reason for recall
Device was shipped without having regulatory approval.
Data sourced from openFDA. This site is unofficial and independent of the FDA.