Z-0202-2014Class II

Synthes 8.5 MM Medullary Reamer

Name: Z-0202-2014 Synthes 8.5 MM Medullary Reamer
Creator: Synthes USA HQ, Inc.
Published: 2013-10-03
License: https://open.fda.gov/license/

Synthes GmbH / initiated 2013-10-03 / Terminated / root cause: design

FDA source

Synthes USA HQ, Inc. began a recall of Synthes 8.5 MM Medullary Reamer Product Usage: An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to... on 2013-10-03. FDA classified it as Class II and gives the reason as "Complaints were received for intraoperative reamer head breakages which can allow for unretrieved fragments of non-implant grade material". 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-0202-2014
Classification: Class II
Status: Terminated
Initiated: 2013-10-03
Posted: 2013-11-13
Terminated: 2016-08-26
Recalling firm: Synthes GmbH
Product: Synthes 8.5 MM Medullary Reamer Product Usage: An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, bmT, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrument, passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, scissors, screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trephine, wire twister, and wrench.
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: Complaints were received for intraoperative reamer head breakages which can allow for unretrieved fragments of non-implant grade material.
Root cause tag: design
FDA root cause: Device Design
Action: Synthes sent an Urgent Notice: Voluntary Medical Device Recall Notification letters, dated October 3, 2013, to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to review their inventory and immediately remove the affected lots from stock. For questions call 610-719-5450 or contact your Synthes Sales Consultant.
Quantity in commerce: 2979
Distribution: Worldwide Distribution: USA (Nationwide) and countries of: Canada and Mexico.
Product codes and lots: Part No. 352.085 with lot numbers 20141 through 24510, and 4399543 through 5870257

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0202-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0202-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-20	2013-11-12

Product code LXH

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)