A.L.P.S., 3.5mm x 60 mm Cortical Locking Screw. Bone fixation screw
FDA device recall Z-2058-2015 · posted 2015-07-10 · Terminated
Recall details
- Recalling firm
- Biomet, Inc.
- Reason for recall
- Sterile packaging was not sealed. The implantation of an unsterile screw may lead to infection.
- Action taken
- On 6/4/2015, URGENT MEDICAL DEVICE RECALL NOTICE notifications were sent to the affected distributors with instructions for removing 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
- Packaging
- Status
- Terminated
- Product code
- HRS
- Quantity affected
- 50 units
- Distribution
- Domestic: None. International: Netherlands and Japan
- Date initiated
- 2015-06-04
- Date posted
- 2015-07-10
- Date terminated
- 2016-03-22
- Location
- Warsaw, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TRAUMA INTERNAL FIXATION SYSTEMS (K111663) | DePuy Orthopaedics, Inc. | 2012-03-12 |