Z-1783-2013Class II

Rultract Retractor Ratchet Cover Plate Distributed by Pemco, Inc., Cleveland, OH 44131 Surgical retractor...

Name: Z-1783-2013 Rultract Retractor Ratchet Cover Plate Distributed by Pemco, Inc., Cleveland, OH 44131 Surgical retractor...
Creator: Pemco Inc
Published: 2013-07-10
License: https://open.fda.gov/license/

Pemco Inc / initiated 2013-07-10 / Terminated / root cause: manufacturing process

FDA source

Pemco Inc began a recall of Rultract Retractor Ratchet Cover Plate Distributed by Pemco, Inc., Cleveland, OH 44131 Surgical retractor used to lift the incision site on 2013-07-10. FDA classified it as Class II and gives the reason as "The firm became aware of the problem when a ratchet cover plate on a device was returned for repair showed signs of corrosion". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1783-2013
Classification: Class II
Status: Terminated
Initiated: 2013-07-10
Posted: 2013-07-22
Terminated: 2014-02-11
Recalling firm: Pemco Inc
Product: Rultract Retractor Ratchet Cover Plate Distributed by Pemco, Inc., Cleveland, OH 44131 Surgical retractor used to lift the incision site
Product code: GAD Retractor
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.
Root cause tag: manufacturing process
FDA 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 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1783-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1783-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-31	2013-07-22

Product code GAD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)