Z-0989-2015Class II

Civco, MTSR02 Shoulder Retractor with Sherpa Wrist Loops Kit with Base, Non-sterile re-usable wool wrist...

Name: Z-0989-2015 Civco, MTSR02 Shoulder Retractor with Sherpa Wrist Loops Kit with Base, Non-sterile re-usable wool wrist...
Creator: Med Tec Inc
Published: 2014-12-11
License: https://open.fda.gov/license/

Medtec LLC / initiated 2014-12-11 / Terminated / root cause: design

FDA source

Med Tec Inc began a recall of 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... on 2014-12-11. FDA classified it as Class II and gives the reason as "The product (wool wrist loop) was manufactured 7cm shorter than product specifications". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0989-2015
Classification: Class II
Status: Terminated
Initiated: 2014-12-11
Posted: 2015-01-15
Terminated: 2017-02-03
Recalling firm: Medtec LLC
Product: 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.
Product code: FMQ Restraint, Protective
Reason for recall: The product (wool wrist loop) was manufactured 7cm shorter than product specifications.
Root cause tag: design
FDA root cause: Component design/selection
Action: The firm sent e-mailed Field Safety Notice letters and contacted customers via phone on December 11, 2014, informing customers of the issue with the product. Customers were advised they may accept the product as is or request a replacement. A response form was enclosed for consignees to indicate the status of the product. Please contact a CIVCO insides sales representative for additional assistance. You may reach your representative by calling CIVCO Medical Solutions, Radiation Oncology, at 800-842-8688 or 712-737- 8688 between 8:00AM and 5:00PM CST.
Quantity in commerce: 11
Distribution: Worldwide Distribution - US Distribution to the states of : AZ, MO, PA and WI., and the countries of : Austria, India and Japan.
Product codes and lots: Lot: M612690 REF: 20SR02SUB2

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0989-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0989-2015	Class II	Terminated	Voluntary: Firm initiated	2015-01-21	2015-01-15
Z-0990-2015	Class II	Terminated	Voluntary: Firm initiated	2015-01-21	2015-01-15

Product code FMQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)