Z-0381-2014Class II

REF 200068 Security (TM) Enclosed Carpal Tunnel System Blade ( Single) ABS /Stainless Steel Sterile Device...

Name: Z-0381-2014 REF 200068 Security (TM) Enclosed Carpal Tunnel System Blade ( Single) ABS /Stainless Steel Sterile Device...
Creator: Biomet, Inc.
Published: 2013-10-25
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2013-10-25 / Terminated / root cause: manufacturing process

FDA source

Biomet, Inc. began a recall of REF 200068 Security (TM) Enclosed Carpal Tunnel System Blade ( Single) ABS /Stainless Steel Sterile Device, Single Use Only. Designed to release the transverse... on 2013-10-25. FDA classified it as Class II and gives the reason as "Security Blades were manufactured oversized and potentially won't advance or may be difficult to advance through the mating Security Clip". 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-0381-2014
Classification: Class II
Status: Terminated
Initiated: 2013-10-25
Posted: 2013-11-22
Terminated: 2015-05-06
Recalling firm: Zimmer GmbH
Product: REF 200068 Security (TM) Enclosed Carpal Tunnel System Blade ( Single) ABS /Stainless Steel Sterile Device, Single Use Only. Designed to release the transverse carpal ligament.
Product code: FZX Guide, Surgical, Instrument
Reason for recall: Security Blades were manufactured oversized and potentially won't advance or may be difficult to advance through the mating Security Clip.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 10/25/2013 Urgent Medical Device Recall Notifications were sent to each Distributor and Risk/Recall Manager at each direct account identifying the recalled device, possible adverse health consequences and instructing consignees to immediately locate and remove devices from circulation, following instructions on the FAX back form and returning it within 3 business days to FAX 574-372-1683 and returning product to Biomet Return Goods, 56 East Bell Drive Warsaw In 46580. Questions should be directed to 574-372-1570 M-F, 8 a.m. to 5 p.m.
Quantity in commerce: 1130
Distribution: Worldwide Distribution: USA (nationwide) and Internationally to Japan.
Product codes and lots: Catalog Number: 200068 Medical Device Listing Number: B008657 Lot Number Identification: 088610, 090600, 143810, 257060, 289900, 365910, 460490, 558300, 626660, 697320,767260,795090,857730,864640,979680

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0381-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0381-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-04	2013-11-22

Product code FZX

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)