Z-1783-2013 Class II Terminated
FDA device recall Z-1783-2013 was initiated by Pemco Inc on July 10, 2013 and is designated Class II. 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. The recall status is terminated (terminated February 11, 2014). Affected quantity: 87 units.
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.