Recall Z-1446-2015
Biomet, Inc. · initiated March 18, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: REF 131227222 LOT RM105E
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.
FDA-determined cause: Nonconforming Material/Component
Action taken
On 3/18/2015, Biomet issued an URGENT MEDICAL DEVICE RECALL NOTICE to affected distributors and one medical facility. Notification included the reason for recall, description of affected product, statement of no expected patient health risk, and actions required of the addressee. Questions related to the recall notification should be directed to (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m.
Details
- Recall number
- Z-1446-2015
- Initiated
- March 18, 2015
- Posted by FDA
- April 14, 2015
- Terminated
- December 11, 2015
- Product code
- LXT – Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
- Quantity
- 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.
- Recalling firm
- Biomet, Inc., Warsaw, IN