Z-1457-2014Class II

The Synthes Hohmann Retractor, 43 mm Long Shank, Angled 235 mm

Name: Z-1457-2014 The Synthes Hohmann Retractor, 43 mm Long Shank, Angled 235 mm
Creator: Synthes, Inc.
Published: 2014-02-11
License: https://open.fda.gov/license/

Synthes GmbH / initiated 2014-02-11 / Terminated / root cause: labeling and UDI

FDA source

Synthes, Inc. began a recall of The Synthes Hohmann Retractor, 43 mm Long Shank, Angled 235 mm Product Usage: Used to expose bone for procedures on 2014-02-11. FDA classified it as Class II and gives the reason as "The Synthes Hohmann Retractor was mis-etched on the product and package as part number 399.24 instead of part number 399.22". 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-1457-2014
Classification: Class II
Status: Terminated
Initiated: 2014-02-11
Posted: 2014-04-15
Terminated: 2015-09-10
Recalling firm: Synthes GmbH
Product: The Synthes Hohmann Retractor, 43 mm Long Shank, Angled 235 mm Product Usage: Used to expose bone for procedures.
Product code: GAD Retractor
Reason for recall: The Synthes Hohmann Retractor was mis-etched on the product and package as part number 399.24 instead of part number 399.22.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: Synthes sent an Urgent Notice: Medical Device Recall letter dated February 11, 2014, to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to Complete the attached Verification Section form. For questions call 610-719-5450.
Quantity in commerce: 20
Distribution: Worldwide Distribution - USA Nationwide Distribution in the states of: TN, MD, NY, IN, NJ, WA, VA,and the country of Canada.
Product codes and lots: part no. 399.24, lot number T974302

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1457-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1457-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-23	2014-04-15

Product code GAD

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)