Gentle Threads Interference Screw 10x25mm Round Head. An interference fixation screw for use in soft tissue reattachment procedures.
Reported: July 8, 2015 Initiated: June 3, 2015 #Z-1944-2015
Product Description
Gentle Threads Interference Screw 10x25mm Round Head. 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.
Details
- Recalling Firm
- Biomet, Inc.
- Units Affected
- 53 units
- Distribution
- Distribution-Domestic: None. International: Australia, Mexico, Chile, Costa Rica, Netherlands, and Brazil.
- Location
- Warsaw, IN
Frequently Asked Questions
What product was recalled? ▼
Gentle Threads Interference Screw 10x25mm Round Head. An interference fixation screw for use in soft tissue reattachment procedures.. Recalled by Biomet, Inc.. Units affected: 53 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 8, 2015. Severity: Moderate. Recall number: Z-1944-2015.
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