Z-1446-2015 Class II Terminated
FDA device recall Z-1446-2015 was initiated by Biomet, Inc. on Mar 18, 2015 and is designated Class II. Reason for recall: A Biomet investigation found that the Low Profile Non-Locking Screw 2.7mmx22mm screw (Part Number: 131227222 Lot: RM105E) was anodized green and should have been anodized gold per the print. The recall status is terminated (terminated Dec 11, 2015). Affected quantity: 45.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 22, 2015
- Initiation Date
- Mar 18, 2015
- Termination Date
- Dec 11, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 45
Product Description
LOW PROFILE NON-LOCK SCREW; 2.7mm x 22 mm; REF 131227222; LOT RM105E. Provides the orthopaedic surgeon a means of bone fixation and helps generally in the management of fractures and reconstructive surgeries.
Reason for Recall
A Biomet investigation found that the Low Profile Non-Locking Screw 2.7mmx22mm screw (Part Number: 131227222 Lot: RM105E) was anodized green and should have been anodized gold per the print.
Distribution Pattern
Nationwide Distribution-including the states of CA, IA, NY, FL, PA, UT, NC, SC, KY, CO, MA, GA, WA, TX, OK, and IL.
Code Information
REF 131227222 LOT RM105E
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1446-2015
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026