Z-1741-2015Class II

Unilateral external fixation ankle clamp

Name: Z-1741-2015 Unilateral external fixation ankle clamp
Creator: Biomet, Inc.
Published: 2015-05-01
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2015-05-01 / Terminated / root cause: manufacturing process

FDA source

Biomet, Inc. began a recall of Unilateral external fixation ankle clamp Product Usage: Unilateral external fixation for use treatment of bone conditions amenable to treatment by use of... on 2015-05-01. FDA classified it as Class II and gives the reason as "Ankle clamp was assembled incorrectly; the offset of the pin to the pivot point is reversed. This prevents complete range of motion and if pushed too far may loosen the pin from the bone. A revision surgery may be...". 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-1741-2015
Classification: Class II
Status: Terminated
Initiated: 2015-05-01
Posted: 2015-06-09
Terminated: 2015-12-08
Recalling firm: Zimmer GmbH
Product: Unilateral external fixation ankle clamp Product Usage: Unilateral external fixation for use treatment of bone conditions amenable to treatment by use of external fixation modality
Product code: KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Reason for recall: Ankle clamp was assembled incorrectly; the offset of the pin to the pivot point is reversed. This prevents complete range of motion and if pushed too far may loosen the pin from the bone. A revision surgery may be necessary to adequately reconnect the fixator to the bone.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Biomet sent an URGENT MEDICAL DEVICE RECALL NOTICE letter dated May 1, 2015 to the affected distributors and implanting surgeons. The recall letter included a description of the reason for the recall, affected product, consignee responsibilities, and distributor instructions for responding to the formal recall notification. Consignees were instructed to return the affected product and continued monitoring of patients. Questions related to this notice should be directed to (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m.
Quantity in commerce: 19
Distribution: US Nationwide Distribution in the states of CA, TX, FL, NC, MI, GA.
Product codes and lots: Part 14-450510 Lots:268000, 466170, and 813950

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1741-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1741-2015	Class II	Terminated	Voluntary: Firm initiated	2015-06-17	2015-06-09

Product code KTT

K111376Class IIConstrux External Fixation DeviceEbi, LLC / cleared 2011-08-03

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)