—#150844

Product

Synthes Flexible Shaft, Orthopedic manual surgical instrument The Flexible shafts are intended for use as an optional reaming step in intramedullary nailing systems.

FDA product code: HTO — Reamer
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: Part Number 352.040 - Lot # 9947895, L084498 Part Number 352.044 - Lot # 9916503 9916508,L000158,L000160,L000573,L000603,L000604,L000605,L000607,L000632 L082974

Why it was recalled

Non-conforming material used.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Synthes (USA) Products LLC
Address: 1301 Goshen Pkwy, West Chester, Pennsylvania 19380-5986

Distribution

Distribution pattern: US Nationwide Distribution.

Timeline

Recall initiated: 2016-10-31
Posted by FDA: 2016-11-23
Terminated: 2017-06-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #150844. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.