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Terminated

Rultract Retractor Ratchet Cover Plate Distributed by Pemco, Inc., Cleveland, OH 44131 Surgical retractor used to lift the incision site

FDA Recall Z-1783-2013 · Posted 2013-07-22

Recalling FirmPemco Inc
Recall StatusTerminated
Product CodeGAD
Date Initiated2013-07-10
Date Terminated2014-02-11
Product Quantity87 units

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.

Firm 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.

Root Cause

Nonconforming Material/Component

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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