Z-0656-2017Class II

Synthes Flexible Shaft, Orthopedic manual surgical instrument The Flexible shafts are intended for use as an...

Name: Z-0656-2017 Synthes Flexible Shaft, Orthopedic manual surgical instrument The Flexible shafts are intended for use as an...
Creator: Synthes (USA) Products LLC
Published: 2016-10-31
License: https://open.fda.gov/license/

Synthes (USA) Products LLC / initiated 2016-10-31 / Terminated

FDA source

Synthes (USA) Products LLC began a recall of Synthes Flexible Shaft, Orthopedic manual surgical instrument The Flexible shafts are intended for use as an optional reaming step in intramedullary nailing... on 2016-10-31. FDA classified it as Class II and gives the reason as "Non-conforming material used". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0656-2017
Classification: Class II
Status: Terminated
Initiated: 2016-10-31
Posted: 2016-11-23
Terminated: 2017-06-12
Recalling firm: Synthes (USA) Products LLC
Product: Synthes Flexible Shaft, Orthopedic manual surgical instrument The Flexible shafts are intended for use as an optional reaming step in intramedullary nailing systems.
Product code: HTO Reamer
Reason for recall: Non-conforming material used.
FDA root cause: Under Investigation by firm
Action: The firm, DePuy Synthes, mailed an "URGENT NOTICE: MEDICAL DEVICE RECALL" letter dated 11/2016 to customers who were affected by the recall. The letter described the product, problem and actions to be taken. The customers were instructed to immediately review your inventory to identify and quarantine all affected products; if you have product to return call DePuy Synthes at 1-800-479-6329 to obtain an RA; complete and return the Verification Section with the product to: Credit/Returns, DePuy Synthes, 1101 Synthes Avenue, Monument, CO 80132 within 30 business days; send a copy of the completed Verification section via fax to 888-257-7905 or scan/email: [email protected], even if you have no product to return; forward notice to anyone in your facility that needs to be informed; if any of the affected product has been forwarded to another facility, contact that facility to arrange return and keep a copy of the notice. If you have any questions, please call 610-719-5450 or contact your DePuy Synthes Sales Consultant.
Quantity in commerce: 198 units
Distribution: US Nationwide Distribution.
Product codes and lots: Part Number 352.040 - Lot # 9947895, L084498 Part Number 352.044 - Lot # 9916503 9916508,L000158,L000160,L000573,L000603,L000604,L000605,L000607,L000632 L082974

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0656-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0656-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-30	2016-11-23

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)