Recall Z-1783-2013— Pemco Inc
Class II · Terminated
Class II FDA medical device recall by Pemco Inc, initiated 2013-07-10, terminated 2014-02-11. FDA's recall record names no specific 510(k) clearance for this event. Product: Rultract Retractor Ratchet Cover Plate Distributed by Pemco, Inc., Cleveland, OH 44131 Surgical retractor used to lift the incision site. Reason: The firm became aware of the problem when a ratchet cover plate on a device was returned for repair showed signs of corrosion..
- Recalling firm
- Pemco Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-07-10
- Terminated
- 2014-02-11
- Firm location
- Independence, OH, United States
Product description
Rultract Retractor Ratchet Cover Plate Distributed by Pemco, Inc., Cleveland, OH 44131 Surgical retractor used to lift the incision site
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.