Z-1446-2015Class II

LOW PROFILE NON-LOCK SCREW; 2.7mm x 22 mm; REF 131227222; LOT RM105E. Provides the orthopaedic surgeon a...

Name: Z-1446-2015 LOW PROFILE NON-LOCK SCREW; 2.7mm x 22 mm; REF 131227222; LOT RM105E. Provides the orthopaedic surgeon a...
Creator: Biomet, Inc.
Published: 2015-03-18
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2015-03-18 / Terminated / root cause: manufacturing process

FDA source

Biomet, Inc. began a recall of 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... on 2015-03-18. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1446-2015
Classification: Class II
Status: Terminated
Initiated: 2015-03-18
Posted: 2015-04-14
Terminated: 2015-12-11
Recalling firm: Zimmer GmbH
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.
Product code: LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 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.
Product codes and lots: REF 131227222 LOT RM105E

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1446-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1446-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-22	2015-04-14

Product code LXT

K112345Class IIDistal Volar Radius Plating SystemsMedos International SARL / cleared 2011-10-31

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)