Z-0941-2013Class II

Large Combination Clamp/Large External Fixation System, Part Number 390.005

Name: Z-0941-2013 Large Combination Clamp/Large External Fixation System, Part Number 390.005
Creator: Synthes USA HQ, Inc.
Published: 2013-01-11
License: https://open.fda.gov/license/

Synthes GmbH / initiated 2013-01-11 / Terminated / root cause: manufacturing process

FDA source

Synthes USA HQ, Inc. began a recall of Large Combination Clamp/Large External Fixation System, Part Number 390.005 Product Usage: Synthes Large External Fixation is intended for use to provide... on 2013-01-11. FDA classified it as Class II and gives the reason as "The L1 hex nuts, used to tighten the Large Combination Clamp, were oversized and the 11 mm sockets and wrenches will not fit on the hex nuts". 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-0941-2013
Classification: Class II
Status: Terminated
Initiated: 2013-01-11
Posted: 2013-03-11
Terminated: 2015-08-31
Recalling firm: Synthes GmbH
Product: Large Combination Clamp/Large External Fixation System, Part Number 390.005 Product Usage: Synthes Large External Fixation is intended for use to provide treatment for long bone and pelvic fractures that require external fixation.
Product code: KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Reason for recall: The L1 hex nuts, used to tighten the Large Combination Clamp, were oversized and the 11 mm sockets and wrenches will not fit on the hex nuts.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Synthes sent an Urgent Notice: Medical Device Recall letter dated January 11, 2013 to all affected customers. The letter identified the affected product, problem, and actions to be taken. Customers were instructed to examine their inventory for the affected product(s), remove them from inventory and return them to Synthes. For questions call 610-719-5450 or email [email protected]
Quantity in commerce: 136
Distribution: USA Nationwide Distribution including the states of AL, AR, AK, CA, FL, ID, KS, LA, MD, MA, MO, NJ, NY, OH, PA, TN, TX, and VA.
Product codes and lots: Lot Numbers 6602070, 6582333, 6581191, and 6581193

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0941-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0941-2013	Class II	Terminated	Voluntary: Firm initiated	2013-03-20	2013-03-11

Product code KTT

K082650Class IISynthes Large External Fixation, Mr ConditionalSynthes (Usa) / cleared 2008-11-18

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)