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 Recall Z-1446-2015 · Posted 2015-04-14
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Recalling FirmBiomet, Inc.
Recall StatusTerminated
Product CodeLXT
Date Initiated2015-03-18
Date Terminated2015-12-11
Product Quantity45
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.
Firm 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.
Root Cause
Nonconforming Material/Component
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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