Device 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.
Z-0990-2015
Product summary
- Firm
- Med Tec Inc
- Event
- Event 69997
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2
- Official record key
device-enforcement:Z-0990-2015
Official wording
Reason: The product (wool wrist loop) was manufactured 7cm shorter than product specifications.
Code information: Lot: M612690 REF: 20SR03
Distribution pattern: Worldwide Distribution - US Distribution to the states of : AZ, MO, PA and WI., and the countries of : Austria, India and Japan.
Derived failure modes
-
Unknown
The product (wool wrist loop) was manufactured 7cm shorter than product specifications.