Z-0585-2016Class II

SYNTHES; 13.5MM Medullary Reamer Head; 352.135 NON STERILE. Part of the Flexible Reamer Set for orthopedic...

Name: Z-0585-2016 SYNTHES; 13.5MM Medullary Reamer Head; 352.135 NON STERILE. Part of the Flexible Reamer Set for orthopedic...
Creator: Synthes (USA) Products LLC
Published: 2015-12-01
License: https://open.fda.gov/license/

Synthes (USA) Products LLC / initiated 2015-12-01 / Terminated / root cause: manufacturing process

FDA source

Synthes (USA) Products LLC began a recall of SYNTHES; 13.5MM Medullary Reamer Head; 352.135 NON STERILE. Part of the Flexible Reamer Set for orthopedic surgical procedures on 2015-12-01. FDA classified it as Class II and gives the reason as "The 13.5mm Medullary Reamer head, lot #F-17180, is etched as dimension 13.5mm while the actual dimension is 14mm". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0585-2016
Classification: Class II
Status: Terminated
Initiated: 2015-12-01
Posted: 2016-01-05
Terminated: 2016-08-26
Recalling firm: Synthes (USA) Products LLC
Product: SYNTHES; 13.5MM Medullary Reamer Head; 352.135 NON STERILE. Part of the Flexible Reamer Set for orthopedic surgical procedures.
Product code: HTO Reamer
Reason for recall: The 13.5mm Medullary Reamer head, lot #F-17180, is etched as dimension 13.5mm while the actual dimension is 14mm.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: On Dec 1, 2015, Synthes issued a recall notification letter and requested that all consignees review inventory and contact Synthes for a return authorization number. The verification form is to be completed and sent to Stericycle.
Quantity in commerce: 65
Distribution: US nationwide distibution.
Product codes and lots: Part number: 352.135; Lot number: F-17180

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0585-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0585-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-13	2016-01-04

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)