Recall Z-1783-2013 ยท GAD Retractor
Pemco Inc
Rultract Retractor Ratchet Cover Plate Distributed by Pemco, Inc., Cleveland, OH 44131 Surgical retractor used to lift the incision site
| Date | Jul 22, 2013 (initiated Jul 10, 2013) |
| Status | Terminated |
| Reason | The firm became aware of the problem when a ratchet cover plate on a device was returned for repair showed signs of corrosion. |
| Root cause | 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 questio |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.