—#122472

Product

Synthes 8.5 MM Medullary Reamer Product Usage: An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, bmT, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrument, passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, scissors, screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trephine, wire twister, and wrench.

FDA product code: LXH — Orthopedic Manual Surgical Instrument
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: Part No. 352.085 with lot numbers 20141 through 24510, and 4399543 through 5870257

Why it was recalled

Complaints were received for intraoperative reamer head breakages which can allow for unretrieved fragments of non-implant grade material.

Root cause (FDA determination)

Device Design

Action the firm took

Synthes sent an Urgent Notice: Voluntary Medical Device Recall Notification letters, dated October 3, 2013, to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to review their inventory and immediately remove the affected lots from stock. For questions call 610-719-5450 or contact your Synthes Sales Consultant.

Recalling firm

Firm: Synthes USA HQ, Inc.
Address: 1302 Wrights Ln E, West Chester, Pennsylvania 19380-3417

Distribution

Distribution pattern: Worldwide Distribution: USA (Nationwide) and countries of: Canada and Mexico.

Timeline

Recall initiated: 2013-10-03
Posted by FDA: 2013-11-13
Terminated: 2016-08-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #122472. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.