FDA Medical Device Recalls (openFDA)
Synthes (USA) Products LLC: Synthes Flexible Shaft, Orthopedic manual surgical instrument The Flexible shafts are intended for use as an optional reaming step in intramedullary nailing systems.
- Recall number
- Z-0656-2017
- 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.
- Status
- Terminated
- Initiated
- 2016-10-31
- Posted
- 2016-11-23
- Terminated
- 2017-06-12
- Reason
- Non-conforming material used.
- 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: Synthes3503@stericycle.com, 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
- 198 units
- Distribution
- US Nationwide Distribution.
- Lot, serial or model codes
- Part Number 352.040 - Lot # 9947895, L084498 Part Number 352.044 - Lot # 9916503 9916508,L000158,L000160,L000573,L000603,L000604,L000605,L000607,L000632 L082974
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HTO
- Firm FEI
- 3008812560
- Firm city
- West Chester
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28