Recall Z-1446-2015— Biomet, Inc.

Name: FDA recall Z-1446-2015
Creator: U.S. Food and Drug Administration
Published: 2015-03-18

Class II · Terminated

Class II FDA medical device recall by Biomet, Inc., initiated 2015-03-18, terminated 2015-12-11. It names one FDA 510(k) clearance: K112345. 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.. 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..

Recalling firm: Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-03-18
Terminated: 2015-12-11
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K112345 — DISTAL VOLAR RADIUS PLATING SYSTEMSMedos International SARL·cleared 2011-10-31

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.