Recall Z-0990-2015— Med Tec Inc
Class II · Terminated
Class II FDA medical device recall by Med Tec Inc, initiated 2014-12-11, terminated 2017-02-03. FDA's recall record names no specific 510(k) clearance for this event. Product: Civco, MTSR03 Shoulder Retractor with Wrist Loops Kit with Base, plus two pairs of wrist loops (nylon and sherpa), Non-sterile re-usable wool wrist strap, REF: 20SR03, Rx The devise is intended to pull patients shoulders down for clearance when treating lateral fields to the neck.. Reason: The product (wool wrist loop) was manufactured 7cm shorter than product specifications..
- Recalling firm
- Med Tec Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-12-11
- Terminated
- 2017-02-03
- Firm location
- Orange City, IA, United States
Product description
Civco, MTSR03 Shoulder Retractor with Wrist Loops Kit with Base, plus two pairs of wrist loops (nylon and sherpa), Non-sterile re-usable wool wrist strap, REF: 20SR03, Rx The devise is intended to pull patients shoulders down for clearance when treating lateral fields to the neck.
Reason for recall
The product (wool wrist loop) was manufactured 7cm shorter than product specifications.
Data sourced from openFDA. This site is unofficial and independent of the FDA.