Z-0394-2014Class II

Synthes Spiked Washers 13.5/6.5 Spiked Washers 13.5/6.5 are intended to be used in ligament reattachment or...

Name: Z-0394-2014 Synthes Spiked Washers 13.5/6.5 Spiked Washers 13.5/6.5 are intended to be used in ligament reattachment or...
Creator: Synthes USA HQ, Inc.
Published: 2013-10-03
License: https://open.fda.gov/license/

Synthes GmbH / initiated 2013-10-03 / Terminated / root cause: labeling and UDI

FDA source

Synthes USA HQ, Inc. began a recall of Synthes Spiked Washers 13.5/6.5 Spiked Washers 13.5/6.5 are intended to be used in ligament reattachment or fixation, specifically readaptation of torn or... on 2013-10-03. FDA classified it as Class II and gives the reason as "During a retrospective assessment, Spiked Washers 13.5/6.5 were discovered to be mislabeled as Spiked Washers 13.5/5.5". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0394-2014
Classification: Class II
Status: Terminated
Initiated: 2013-10-03
Posted: 2013-11-26
Terminated: 2015-12-18
Recalling firm: Synthes GmbH
Product: Synthes Spiked Washers 13.5/6.5 Spiked Washers 13.5/6.5 are intended to be used in ligament reattachment or fixation, specifically readaptation of torn or avulsed ligaments.
Product code: HTN Washer, Bolt Nut
Reason for recall: During a retrospective assessment, Spiked Washers 13.5/6.5 were discovered to be mislabeled as Spiked Washers 13.5/5.5.
Root cause tag: labeling and UDI
FDA root cause: Finished device change control
Action: SYNTHES sent an Urgent Notice: Medical Device Recall letter dated October 3, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed call Synthes at 1-800-479-6329 to obtain a Return Authorization Number, complete the Verification Section at the end of the letter by checking the appropriate box indicating affected product located. Return the Verification Form to: Credit/Returns Synthes 1101 Synthes Avenue, Monument, CO 80132 Customers were also asked to return the Verification Form indicating they did not have the affected product also. All documents were to be returned to Synthes by: Fax 1-877-270-5855 Scan/email: [email protected] Customers with questions were instructed to call 610-719-5450 or contact their Synthes Sales Consultant For questions regarding this recall call 610-719-5000..
Quantity in commerce: 3087
Distribution: Nationwide Distribution
Product codes and lots: part 219.951 with multiple lot#: 2335941 2339634 2397429 2405812 2440475 2442736 2496414 5661855 5663841

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0394-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0394-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-04	2013-11-26

Product code HTN

K011583Class IISpiked WasherSynthes (Usa) / cleared 2002-01-30

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)