Z-1952-2013Class II

Synthes Flexible Medullary Reamer. Intended to be used to facilitate the preparation of the intramedullary...

Name: Z-1952-2013 Synthes Flexible Medullary Reamer. Intended to be used to facilitate the preparation of the intramedullary...
Creator: Synthes USA HQ, Inc.
Published: 2013-06-11
License: https://open.fda.gov/license/

Synthes GmbH / initiated 2013-06-11 / Terminated / root cause: design

FDA source

Synthes USA HQ, Inc. began a recall of Synthes Flexible Medullary Reamer. Intended to be used to facilitate the preparation of the intramedullary cavity on 2013-06-11. FDA classified it as Class II and gives the reason as "Due to the coiled design for this product, the product is difficult to clean and the potential for corrosion on the device exists. The potential for harm exists if there is an introduction of foreign material at the...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1952-2013
Classification: Class II
Status: Terminated
Initiated: 2013-06-11
Posted: 2013-08-12
Terminated: 2015-08-31
Recalling firm: Synthes GmbH
Product: Synthes Flexible Medullary Reamer. Intended to be used to facilitate the preparation of the intramedullary cavity.
Product code: HTO Reamer
Reason for recall: Due to the coiled design for this product, the product is difficult to clean and the potential for corrosion on the device exists. The potential for harm exists if there is an introduction of foreign material at the operative site originating from the presence of corrosion and/or the retained undefined material that could not be adequately cleaned.
Root cause tag: design
FDA root cause: Device Design
Action: Sythes notified direct accounts by letter on 6/11/13 and requested them to check their inventory and remove affected lots from stock. Synthes requested that affected lots be returned and to call Synthes at 1-800-479-6329 for a Return Authorization Number. Completion and return of the Verification section at the end of the letter was requested, including negative responses.
Quantity in commerce: 13,050
Distribution: Nationwide Distribution.
Product codes and lots: All lots with part number 359.106, 359.107, 359.108, 359.109, 359.110, 359.111, 359.112, 359.113, 359.114, 359.115

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1952-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1952-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-21	2013-08-12

Product code HTO

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)