Recall Z-1944-2015
Biomet, Inc. · initiated June 3, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Gentle Threads Interference Screw 10x25mm Round Head. An interference fixation screw for use in soft tissue reattachment procedures.
Codes / lots: Part Number: 905620 Lot: 824610
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.
FDA-determined cause: Mixed-up of materials/components
Action taken
On 6/3/2015, URGENT MEDICAL DEVICE RECALL NOTICE notifications were sent to the affected distributors with instructions for locating and returning the affected product. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Questions related to this notice should be directed to (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m.
Details
- Recall number
- Z-1944-2015
- Initiated
- June 3, 2015
- Posted by FDA
- July 1, 2015
- Terminated
- December 22, 2015
- Product code
- HWC – Screw, Fixation, Bone
- Quantity
- 53 units
- Distribution
- Distribution-Domestic: None. International: Australia, Mexico, Chile, Costa Rica, Netherlands, and Brazil.
- Recalling firm
- Biomet, Inc., Warsaw, IN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1945-2015 Class II | Gentle Threads Interference Screw 9x35mm Full Thread. An interference fixation screw for…Part Number: 905620 Lot: 824610 Gentle Threads Interference Screw 10x25mm Round Head is mixed with the Part… | 06/03/2015Terminated |