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

FDA device recall Z-0656-2017 · posted 2016-11-23 · Terminated

Recall details

Recalling firm

Synthes (USA) Products LLC

Reason for recall

Non-conforming material used.

Action taken

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.

Root cause

Under Investigation by firm

Status

Terminated

Product code

HTO

Quantity affected

198 units

Distribution

US Nationwide Distribution.

Date initiated

2016-10-31

Date posted

2016-11-23

Date terminated

2017-06-12

Location

West Chester, PA