Z-1783-2013 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 31, 2013
- Initiation Date
- July 10, 2013
- Termination Date
- February 11, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 87 units
Product Description
Rultract Retractor Ratchet Cover Plate Distributed by Pemco, Inc., Cleveland, OH 44131 Surgical retractor used to lift the incision site
Reason for Recall
The firm became aware of the problem when a ratchet cover plate on a device was returned for repair showed signs of corrosion.
Distribution Pattern
Worldwide Distribution - USA including AL, CA, CT, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, NC, NJ, NM, NV, OK, PA, TN, TX, UT, VA & WA. Internationally to Czech Republic, Italy, Japan, Korea & Singapore.
Code Information
M/N 4100-IMR-6: S/N's: 4829-4839, 4845-4851, 4857-4871, 4874-4884, 4894-4908 & 4916-4923; M/N 4100-IMR-41: S/N's: 4840-4844, 4852-4856, 4888-4893, 4913-4915 & 4926-4927.