FDA Enforcement
Class II
Terminated
Gentle Threads Interference Screw 9x35mm Full Thread. An interference fixation screw for use in soft tissue reattachment procedures
Recall: Z-1945-2015
·
Reported July 8, 2015
Enforcement
- Recall Number
- Z-1945-2015
- Event ID
- 71526
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Biomet, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- July 8, 2015
- Initiation Date
- June 3, 2015
- Classification Date
- June 30, 2015
- Termination Date
- December 22, 2015
- Address
- 56 E Bell Dr, Warsaw, IN, 46582-6989, United States
Description
Gentle Threads Interference Screw 9x35mm Full Thread. An interference fixation screw for use in soft tissue reattachment procedures
Reason
Part Number: 905620 Lot: 824610 Gentle Threads Interference Screw 10x25mm Round Head is mixed with the Part Number: 905627 Lot: 753410 Gentle Threads Interference Screw 9x35mm Full Thread. If the incorrect screw is used various failures may occur which may ultimately lead to revision surgery or a delay in surgery.
Code Info
Part Number: 905627 Lot: 753410
Distribution
Distribution-Domestic: None. International: Australia, Mexico, Chile, Costa Rica, Netherlands, and Brazil.
Quantity
41 units