Z-0202-2014 Class II Terminated
FDA device recall Z-0202-2014 was initiated by Synthes USA HQ, Inc. on Oct 3, 2013 and is designated Class II. Reason for recall: Complaints were received for intraoperative reamer head breakages which can allow for unretrieved fragments of non-implant grade material. The recall status is terminated (terminated Aug 26, 2016). Affected quantity: 2979.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 20, 2013
- Initiation Date
- Oct 3, 2013
- Termination Date
- Aug 26, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2979
Product Description
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.
Reason for Recall
Complaints were received for intraoperative reamer head breakages which can allow for unretrieved fragments of non-implant grade material.
Distribution Pattern
Worldwide Distribution: USA (Nationwide) and countries of: Canada and Mexico.
Code Information
Part No. 352.085 with lot numbers 20141 through 24510, and 4399543 through 5870257