Gentle Threads Interference Screw 10x25mm Round Head. An interference fixation screw for use in soft tissue reattachment
FDA device recall Z-1944-2015 · posted 2015-07-01 · Terminated
Recall details
- Recalling firm
- Biomet, Inc.
- 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.
- 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.
- Root cause
- Mixed-up of materials/components
- Status
- Terminated
- Product code
- HWC
- Quantity affected
- 53 units
- Distribution
- Distribution-Domestic: None. International: Australia, Mexico, Chile, Costa Rica, Netherlands, and Brazil.
- Date initiated
- 2015-06-03
- Date posted
- 2015-07-01
- Date terminated
- 2015-12-22
- Location
- Warsaw, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| RESORBABLE INTERFERENCE SCREW (K041274) | Arthrotek, Inc. | 2004-07-28 |