FDA Enforcement
Class II
Ongoing
Compress Device Segmental Anchor Plug, 22 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178412
Recall: Z-0376-2024
·
Reported November 29, 2023
Enforcement
- Recall Number
- Z-0376-2024
- Event ID
- 93323
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Biomet, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 29, 2023
- Initiation Date
- October 9, 2023
- Classification Date
- November 21, 2023
- Address
- 56 E Bell Dr, N/A, Warsaw, IN, 46582-6989, United States
Description
Compress Device Segmental Anchor Plug, 22 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178412
Reason
Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
Code Info
Lot Numbers/UDI 332080 (01)00880304259805(17)270706(10)332080; 671760 (01)00880304259805(17)271026(10)671760; 752810 (01)00880304259805(17)270725(10)752810; 856940 (01)00880304259805(17)271030(10)856940; 930700 (01)00880304259805(17)270816(10)930700
Distribution
Worldwide distribution - US Nationwide and the countries of ARGENTINA, AUSTRALIA, CANADA, CHILE, JAPAN, NETHERLANDS, NEW ZEALAND.
Quantity
N/A