The Recall Desk
HighFDA (Devices)·Z-1783-2013·Announced 2013-07-31

Pemco Rultract Retractor Ratchet Cover Plate Recalled for Corrosion

Pemco Inc. is recalling 87 Rultract Retractor Ratchet Cover Plates because a returned unit showed signs of corrosion. The devices are used in surgery to lift incision sites.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a structural defect (corrosion) that poses a risk of harm, but the source text does not report any injuries or illnesses, fitting the criteria for a high-risk product where injury has not yet been reported.

Plain-English summary

Pemco Inc. is recalling 87 units of the Rultract Retractor Ratchet Cover Plate. These surgical retractors are used to lift the incision site during procedures. The recall was initiated after the firm became aware that a ratchet cover plate on a device returned for repair showed signs of corrosion.

The affected units were distributed worldwide, including in the United States and internationally to the Czech Republic, Italy, Japan, Korea, and Singapore. Specific model and serial numbers are listed in the recall documentation. The source text does not report any illnesses or injuries associated with this defect.

Healthcare facilities and consumers should stop using the affected Rultract Retractor Ratchet Cover Plates immediately. Pemco Inc. is the recalling firm and is responsible for managing the recall process.

The recalled product

Product
Rultract Retractor Ratchet Cover Plate Distributed by Pemco, Inc., Cleveland, OH 44131 Surgical retractor used to lift the incision site
Manufacturer
Pemco Inc
Category
Medical Device — Surgical Instruments
Hazard
Affected units
87

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (9)

  • 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.

Distribution

Distributed in 27 states:

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