FDAFDA · Food and drugs·Recall number Z-1783-2013
Rultract Retractor Ratchet Cover Plate Distributed by Pemco, Inc., Cleveland, OH 44131 Surgical retractor used to lift the incision site
Published July 31, 2013 · Recall initiated: July 10, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The firm became aware of the problem when a ratchet cover plate on a device was returned for repair showed signs of corrosion.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Pemco Inc
- Distributor
- 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.
- Lot
- 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.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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