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U.S. Department of Health and Human Services

Class 2 Device Recall Rultract Retractor Ratchet Cover Plate

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 Class 2 Recall
Rultract Retractor Ratchet Cover Plate
see related information
Date Posted July 22, 2013
Recall Status1 Terminated on February 11, 2014
Recall Number Z-1783-2013
Recall Event ID 65679
Product Classification Retractor - Product Code GAD
Product Rultract Retractor Ratchet Cover Plate Distributed by Pemco, Inc., Cleveland, OH 44131 Surgical retractor used to lift the incision site
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.
Recalling Firm/
Manufacturer
Pemco Inc
5663 Brecksville Rd
Independence, Ohio 44131-1510
Manufacturer 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.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action Rultract Skyhook sent a Recall Notification letter dated July 15, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to identify the device and return preferably just the gearbox portion of the device to: Pemco, Inc. Attn: Cover Plate Replacement 5663 Brecksville Road Independence, OH 44131 For customers who are unable to send the gearbox for recall service, Pemco would replace the Cover Plate free of charge. Customers with questions were instructed to call 216-524-2990, ext 103. For questions regarding this recall call 216-524-2990.
Quantity in Commerce 87 units
Distribution 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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