Biomet ARTHROSIMPLICITY KIT EU Item Number: 24-4055
Reported: October 14, 2020 Initiated: September 4, 2020 #Z-0084-2021
Product Description
Biomet ARTHROSIMPLICITY KIT EU Item Number: 24-4055
Reason for Recall
Product not properly being aligned with the adequate gamma sterilization group and result in the product not being properly sterilized
Details
- Recalling Firm
- Biomet, Inc.
- Units Affected
- 4 units OUS
- Distribution
- Nationwide Foreign: Canada, FINLAND, NETHERLANDS, UNITED KINGDOM
- Location
- Warsaw, IN
Frequently Asked Questions
What product was recalled? ▼
Biomet ARTHROSIMPLICITY KIT EU Item Number: 24-4055. Recalled by Biomet, Inc.. Units affected: 4 units OUS.
Why was this product recalled? ▼
Product not properly being aligned with the adequate gamma sterilization group and result in the product not being properly sterilized
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 14, 2020. Severity: Moderate. Recall number: Z-0084-2021.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11