RegWardenFDA facility compliance records
Recall

Class II — Pemco Inc

Recalling firmPEMCO, INC.
Registered facilityPEMCO, INC. (the firm's only registered facility)
ClassificationClass II
StatusTerminated
ReasonThe firm became aware of the problem when a ratchet cover plate on a device was returned for repair showed signs of corrosion.
ProductRultract Retractor Ratchet Cover Plate Distributed by Pemco, Inc., Cleveland, OH 44131 Surgical retractor used to lift the incision site
Quantity87 units
DistributionWorldwide 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.
Initiated2013-07-10
Classified2013-07-22
Terminated2014-02-11
Recall numberZ-1783-2013
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Pemco Inc (Z-1783-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/65679/

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