Recalls / —
—#135057
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.
- FDA product code
- LXT — Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
- Device class
- Class 2
- Medical specialty
- Orthopedic
- 510(k) numbers
- K112345
- Affected lot / code info
- REF 131227222 LOT RM105E
Why it was 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.
Root cause (FDA determination)
Nonconforming Material/Component
Action the firm took
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.
Recalling firm
- Firm
- Biomet, Inc.
- Address
- 56 E Bell Dr, Warsaw, Indiana 46582-6989
Distribution
- 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.
Timeline
- Recall initiated
- 2015-03-18
- Posted by FDA
- 2015-04-14
- Terminated
- 2015-12-11
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #135057. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.