LOW PROFILE NON-LOCK SCREW; 2.7mm x 22 mm; REF 131227222; LOT RM105E. Provides the orthopaedic surgeon a means of bone f
FDA device recall Z-1446-2015 · posted 2015-04-14 · Terminated
Recall details
- Recalling firm
- Biomet, Inc.
- 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.
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- LXT
- Quantity 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.
- Date initiated
- 2015-03-18
- Date posted
- 2015-04-14
- Date terminated
- 2015-12-11
- Location
- Warsaw, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DISTAL VOLAR RADIUS PLATING SYSTEMS (K112345) | Medos International SARL | 2011-10-31 |