Recall Z-0618-2021— 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: K140891. Product: 6.5/8.0mm Cannulated Screw System, BCS Cannulated Screw System (3.0, 4.0/5.0, 6.5/8.0mm), Item numbers 110009929, 110009934, 110009935, 110009936, 110009993, 110009994, 110009996, 110009998, 110010000, 110010003, 110010029, 110010030, 110010032, 110010099 - Product Usage: Fracture fixationof small bones, small bone fragements and long bones.. 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
6.5/8.0mm Cannulated Screw System, BCS Cannulated Screw System (3.0, 4.0/5.0, 6.5/8.0mm), Item numbers 110009929, 110009934, 110009935, 110009936, 110009993, 110009994, 110009996, 110009998, 110010000, 110010003, 110010029, 110010030, 110010032, 110010099 - Product Usage: Fracture fixationof small bones, small bone fragements and long bones.
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.