Device product
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.
Z-1446-2015
Product summary
- Firm
- Biomet, Inc.
- Event
- Event 70837
- Status
- Terminated
- Classification
- Class II
- Quantity
- 45
- Official record key
device-enforcement:Z-1446-2015
Official wording
Reason: 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.
Code information: REF 131227222 LOT RM105E
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.
Derived failure modes
-
Unknown
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.