Z-1945-2015 Class II Terminated
FDA device recall Z-1945-2015 was initiated by Biomet, Inc. on Jun 3, 2015 and is designated Class II. Reason for recall: 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… The recall status is terminated (terminated Dec 22, 2015). Affected quantity: 41 units.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 8, 2015
- Initiation Date
- Jun 3, 2015
- Termination Date
- Dec 22, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 41 units
Product Description
Gentle Threads Interference Screw 9x35mm Full Thread. An interference fixation screw for use in soft tissue reattachment procedures
Reason for Recall
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.
Distribution Pattern
Distribution-Domestic: None. International: Australia, Mexico, Chile, Costa Rica, Netherlands, and Brazil.
Code Information
Part Number: 905627 Lot: 753410
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1945-2015
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026