PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: April 22, 2015 Initiated: March 18, 2015 #Z-1446-2015

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.

Details

Recalling Firm
Biomet, Inc.
Units Affected
45
Distribution
Nationwide Distribution-including the states of CA, IA, NY, FL, PA, UT, NC, SC, KY, CO, MA, GA, WA, TX, OK, and IL.
Location
Warsaw, IN

Frequently Asked Questions

What product was recalled?
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.. Recalled by Biomet, Inc.. Units affected: 45.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on April 22, 2015. Severity: Moderate. Recall number: Z-1446-2015.