FDA Medical Device Recalls (openFDA)
Pemco Inc: Rultract Retractor Ratchet Cover Plate Distributed by Pemco, Inc., Cleveland, OH 44131 Surgical retractor used to lift the incision site
- Recall number
- Z-1783-2013
- 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
- Status
- Terminated
- Initiated
- 2013-07-10
- Posted
- 2013-07-22
- Terminated
- 2014-02-11
- 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 questions regarding this recall call 216-524-2990.
- 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.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GAD
- Firm FEI
- 1519227
- Firm city
- Independence
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28