Z-0404-2014Class II

Synthes 14.5 mm Outer Protection Sleeve for Suprapatellar Synthes 14.5 mm Outer Protection Sleeve for...

Name: Z-0404-2014 Synthes 14.5 mm Outer Protection Sleeve for Suprapatellar Synthes 14.5 mm Outer Protection Sleeve for...
Creator: Synthes (USA) Products LLC
Published: 2013-10-14
License: https://open.fda.gov/license/

Synthes (USA) Products LLC / initiated 2013-10-14 / Terminated / root cause: labeling and UDI

FDA source

Synthes (USA) Products LLC began a recall of Synthes 14.5 mm Outer Protection Sleeve for Suprapatellar Synthes 14.5 mm Outer Protection Sleeve for Suprapatellar is used as part of the Synthes Tibial Nail... on 2013-10-14. FDA classified it as Class II and gives the reason as "Complaints were received reporting that a product packaged as a 14.5 mm Outer Protection Sleeve for Suprapatellar contained a 12.0 mm Outer Protection Sleeve for Suprapatellar". 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-0404-2014
Classification: Class II
Status: Terminated
Initiated: 2013-10-14
Posted: 2013-11-26
Terminated: 2015-08-18
Recalling firm: Synthes (USA) Products LLC
Product: Synthes 14.5 mm Outer Protection Sleeve for Suprapatellar Synthes 14.5 mm Outer Protection Sleeve for Suprapatellar is used as part of the Synthes Tibial Nail System EX to stabilize fractures of the proximal and distal tibia and the tibia shaft, open and closed tibia shaft fractures, certain pre- and post- isthmic fractures, and tibial malunions and non-unions.
Product code: JDS Nail, Fixation, Bone
Reason for recall: Complaints were received reporting that a product packaged as a 14.5 mm Outer Protection Sleeve for Suprapatellar contained a 12.0 mm Outer Protection Sleeve for Suprapatellar.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Synthes sent an Urgent Notice: Medical Device Recall letter dated October 14, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to call Synthes at 1-800-479-6329 if they have any of the affected product to obtain a Return Authorization Number, complete the Verification Section at the end of the letter and return the Verification Form with the affected product to: Credit/Returns Synthes 1101 Synthes Avenue Monument, CO 80132 If customers do not have the affected product they should complete the attached Verification Section and return all documents to Synthes by: Fax: 866-229-7778 Scan/email: [email protected] Customers with questions were instructed to call 610-719-5450. For questions regarding this recall call 610-719-5000.
Quantity in commerce: 55
Distribution: Nationwide Distribution
Product codes and lots: part no. 03010.438S, lot 706802

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0404-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0404-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-04	2013-11-26

Product code JDS

K111667Class IISynthes Suprapatellar Insertion InstrumentsSynthes (Usa) / cleared 2011-12-05

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)