Recall Z-0623-2021— Biomet, Inc.
Class II · Terminated
Class II FDA medical device recall by Biomet, Inc., initiated 2020-11-25, terminated 2024-05-08. It names one FDA 510(k) clearance: K002757. Product: OSS Polyethylene Tibial Bushing, Item number 150476 - Product Usage: intended for use in limb salvage.. Reason: Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device..
- Recalling firm
- Biomet, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-11-25
- Terminated
- 2024-05-08
- Firm location
- Warsaw, IN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
OSS Polyethylene Tibial Bushing, Item number 150476 - Product Usage: intended for use in limb salvage.
Reason for recall
Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
Data sourced from openFDA. This site is unofficial and independent of the FDA.