Z-0527-2013Class II

EBI XFIX DFS Rail System (Adult Rail Gradual Swivel Clamp). The Biomet Rail System consists of a unilateral...

Name: Z-0527-2013 EBI XFIX DFS Rail System (Adult Rail Gradual Swivel Clamp). The Biomet Rail System consists of a unilateral...
Creator: Biomet, Inc.
Published: 2012-11-09
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2012-11-09 / Terminated / root cause: manufacturing process

FDA source

Biomet, Inc. began a recall of EBI XFIX DFS Rail System (Adult Rail Gradual Swivel Clamp). The Biomet Rail System consists of a unilateral external fixator rail, modular bone screw clamps... on 2012-11-09. FDA classified it as Class II and gives the reason as "It was reported that the number scale/graduation markings were missing on 14 pieces of the swivel clamp". 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-0527-2013
Classification: Class II
Status: Terminated
Initiated: 2012-11-09
Posted: 2012-12-17
Terminated: 2013-08-28
Recalling firm: Zimmer GmbH
Product: EBI XFIX DFS Rail System (Adult Rail Gradual Swivel Clamp). The Biomet Rail System consists of a unilateral external fixator rail, modular bone screw clamps, and compression and distraction units. The device is used in the treatment of bone fractures.
Product code: KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Reason for recall: It was reported that the number scale/graduation markings were missing on 14 pieces of the swivel clamp.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: On 11/9/2012 an URGENT MEDICAL DEVICE RECALL NOTIFICATION letter was sent to all consignees (distributors and Doctor notices) informing them of the issue and providing recommended actions. Customer contact number (574) 372-1570 Monday through Friday from 8 am to 5 pm.
Quantity in commerce: 49
Distribution: Worldwide Distribution, including the states of TX, TN, PA, CA, NY, FL, and MI and the countries of Japan and Columbia.
Product codes and lots: Catalog Number 06350 and Lot Number Identification 994790 (packaged as 042210)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0527-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0527-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-26	2012-12-17

Product code KTT

K000083Class IIEbi Xfix Dfs Rail SystemEbi, L.P. / cleared 2000-02-03

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)