Z-0643-2017Class II

2.5 mm TI Calibrated Reaming Rod 850 mm, Sterile

Name: Z-0643-2017 2.5 mm TI Calibrated Reaming Rod 850 mm, Sterile
Creator: Synthes (USA) Products LLC
Published: 2016-10-03
License: https://open.fda.gov/license/

Synthes (USA) Products LLC / initiated 2016-10-03 / Terminated / root cause: manufacturing process

FDA source

Synthes (USA) Products LLC began a recall of 2.5 mm TI Calibrated Reaming Rod 850 mm, Sterile on 2016-10-03. FDA classified it as Class II and gives the reason as "The peel pouches for the affected reaming rods and extraction hooks are delaminating". 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-0643-2017
Classification: Class II
Status: Terminated
Initiated: 2016-10-03
Posted: 2016-11-19
Terminated: 2017-07-06
Recalling firm: Synthes (USA) Products LLC
Product: 2.5 mm TI Calibrated Reaming Rod 850 mm, Sterile
Product code: HTO Reamer
Reason for recall: The peel pouches for the affected reaming rods and extraction hooks are delaminating.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: DePuy Synthes mailed a Customer Safety Advisory Notice on October 19, 2016 to affected customers advising them of the malfunction, potential risks and the actions needed to be taken to avoid injury, as they work on a solution to correct the problem.
Quantity in commerce: 260 units
Distribution: Distributed Nationwide
Product codes and lots: Catalog ID 359.083S, Lot Numbers: H115566; H116597; H116601; H117049

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0643-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0637-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-30	2016-11-19
Z-0638-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-30	2016-11-19
Z-0639-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-30	2016-11-19
Z-0640-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-30	2016-11-19
Z-0641-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-30	2016-11-19
Z-0642-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-30	2016-11-19
Z-0643-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-30	2016-11-19
Z-0644-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-30	2016-11-19

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)