Recall Z-1446-2015 ยท LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
Biomet, Inc.
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.
| Date | Apr 14, 2015 (initiated Mar 18, 2015) |
| Status | Terminated |
| 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. |
| Root cause | Nonconforming Material/Component |
| Action | 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. |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K112345 | DISTAL VOLAR RADIUS PLATING SYSTEMS Medos International SARL, Oct 31, 2011 |