Recall Z-1944-2015— Biomet, Inc.
Class II · Terminated
Class II FDA medical device recall by Biomet, Inc., initiated 2015-06-03, terminated 2015-12-22. It names one FDA 510(k) clearance: K041274. Product: Gentle Threads Interference Screw 10x25mm Round Head. 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..
- Recalling firm
- Biomet, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-06-03
- Terminated
- 2015-12-22
- 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
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.