CLASS II Device recall · Reported 22 Apr 2015 · FDA Enforcement Report

Low Profile Non-lock Screw recalled by Biomet

Biomet is recalling Low Profile Non-lock Screw, distributed nationwide in the US. The recall was initiated on 18 Mar 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesREF 131227222 LOT RM105E

Quantity recalled45

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1446-2015
FDA event ID: 70837
Recalling firm: Biomet, Warsaw, IN
Classification: Class II
Status: Terminated
Recall initiated: 18 Mar 2015
FDA classified: 14 Apr 2015
Reported: 22 Apr 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Hip & Knee Implants

Timeline

18 Mar 2015	Recall initiated by company
14 Apr 2015	Classified by FDA	+27 days
22 Apr 2015	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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.

Where it was distributed

Nationwide Distribution-including the states of CA, IA, NY, FL, PA, UT, NC, SC, KY, CO, MA, GA, WA, TX, OK, and IL.

Nationwide California Colorado Florida Georgia Iowa Illinois Kentucky Massachusetts North Carolina New York Oklahoma Pennsylvania South Carolina Texas Utah Washington

Questions about this recall

Why was it 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.

Which lots are affected?

REF 131227222 LOT RM105E

Where was it sold?

Nationwide Distribution-including the states of CA, IA, NY, FL, PA, UT, NC, SC, KY, CO, MA, GA, WA, TX, OK, and IL.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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