Z-2058-2015 Class II Terminated
FDA device recall Z-2058-2015 was initiated by Biomet, Inc. on Jun 4, 2015 and is designated Class II. Reason for recall: Sterile packaging was not sealed. The implantation of an unsterile screw may lead to infection. The recall status is terminated (terminated Mar 22, 2016). Affected quantity: 50 units.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 22, 2015
- Initiation Date
- Jun 4, 2015
- Termination Date
- Mar 22, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 50 units
Product Description
A.L.P.S., 3.5mm x 60 mm Cortical Locking Screw. Bone fixation screw
Reason for Recall
Sterile packaging was not sealed. The implantation of an unsterile screw may lead to infection.
Distribution Pattern
Domestic: None. International: Netherlands and Japan
Code Information
Part number:856135060 Lot: 061300
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2058-2015
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026