Device product
Rultract Retractor Ratchet Cover Plate Distributed by Pemco, Inc., Cleveland, OH 44131 Surgical retractor used to lift the incision site
Z-1783-2013
Product summary
- Firm
- Pemco Inc
- Event
- Event 65679
- Status
- Terminated
- Classification
- Class II
- Quantity
- 87 units
- Official record key
device-enforcement:Z-1783-2013
Official wording
Reason: The firm became aware of the problem when a ratchet cover plate on a device was returned for repair showed signs of corrosion.
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.
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.
Derived failure modes
-
Unknown
The firm became aware of the problem when a ratchet cover plate on a device was returned for repair showed signs of corrosion.