CLASS II Device recall · Reported 21 Jan 2015 · FDA Enforcement Report
Civco, MTSR03 Shoulder Retractor with Wrist Loops Kit recalled
Med Tec is recalling Civco, MTSR03 Shoulder Retractor with Wrist Loops Kit with Base, plus two pairs of wrist, distributed in Arizona, Missouri, Pennsylvania, Wisconsin. The recall was initiated on 11 Dec 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0990-2015
- FDA event ID
- 69997
- Recalling firm
- Med Tec, Orange City, IA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 Dec 2014
- FDA classified
- 15 Jan 2015
- Reported
- 21 Jan 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Sterility
- Device type
- Surgical Instruments
Timeline
| 11 Dec 2014 | Recall initiated by company | |
| 15 Jan 2015 | Classified by FDA | +35 days |
| 21 Jan 2015 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The product (wool wrist loop) was manufactured 7cm shorter than product specifications.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
Worldwide Distribution - US Distribution to the states of : AZ, MO, PA and WI., and the countries of : Austria, India and Japan.
Questions about this recall
Is Civco, MTSR03 Shoulder Retractor with Wrist Loops Kit with Base, plus two pairs of wrist recalled?
Yes. Med Tec recalled Civco, MTSR03 Shoulder Retractor with Wrist Loops Kit with Base, plus two pairs of wrist on 11 Dec 2014. The recall is Class II and its status is Terminated. Recall number Z-0990-2015.
Why was it recalled?
The product (wool wrist loop) was manufactured 7cm shorter than product specifications.
Which lots are affected?
Lot: M612690 REF: 20SR03
Where was it sold?
Worldwide Distribution - US Distribution to the states of : AZ, MO, PA and WI., and the countries of : Austria, India and Japan.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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