Device product
A.L.P.S., 3.5mm x 60 mm Cortical Locking Screw. Bone fixation screw
Z-2058-2015
Product summary
- Firm
- Biomet, Inc.
- Event
- Event 71423
- Status
- Terminated
- Classification
- Class II
- Quantity
- 50 units
- Official record key
device-enforcement:Z-2058-2015
Official wording
Reason: Sterile packaging was not sealed. The implantation of an unsterile screw may lead to infection.
Code information: Part number:856135060 Lot: 061300
Distribution pattern: Domestic: None. International: Netherlands and Japan
Derived failure modes
-
Unknown
Sterile packaging was not sealed. The implantation of an unsterile screw may lead to infection.