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Class 2 Device Recall Rultract Retractor Ratchet Cover Plate |
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Date Initiated by Firm |
July 10, 2013 |
Date Posted |
July 22, 2013 |
Recall Status1 |
Terminated 3 on February 11, 2014 |
Recall Number |
Z-1783-2013 |
Recall Event ID |
65679 |
Product Classification |
Retractor - Product Code GAD
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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 OH 44131-1510
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For Additional Information Contact |
216-524-2990
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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.
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FDA Determined Cause 2 |
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
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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