Z-0989-2015 Class II Terminated
FDA device recall Z-0989-2015 was initiated by Med Tec Inc on December 11, 2014 and is designated Class II. Reason for recall: The product (wool wrist loop) was manufactured 7cm shorter than product specifications. The recall status is terminated (terminated February 3, 2017). Affected quantity: 11.
Recall Details
- Product Type
- Devices
- Report Date
- January 21, 2015
- Initiation Date
- December 11, 2014
- Termination Date
- February 3, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11
Product Description
Civco, MTSR02 Shoulder Retractor with Sherpa Wrist Loops Kit with Base, Non-sterile re-usable wool wrist strap, REF: 20SR02SUB2, Rx Only, 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.
Distribution Pattern
Worldwide Distribution - US Distribution to the states of : AZ, MO, PA and WI., and the countries of : Austria, India and Japan.
Code Information
Lot: M612690 REF: 20SR02SUB2