The Recall Desk
LowFDA (Devices)·Z-0989-2015·Announced 2015-01-21

Med Tec Recalls Short Wool Wrist Loops for Shoulder Retractors

Med Tec Inc is recalling 11 units of a wool wrist loop component for shoulder retractors because the items were manufactured 7cm shorter than specifications.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The defect is a dimensional manufacturing error (7cm shorter) with no reported injuries, illnesses, or functional safety hazards explicitly stated in the source text, fitting the criteria for cosmetic or minor defects.

Plain-English summary

Med Tec Inc is recalling 11 units of the Civco MTSR02 Shoulder Retractor with Sherpa Wrist Loops Kit with Base, specifically the non-sterile re-usable wool wrist strap (REF: 20SR02SUB2). The product is intended to pull patients' shoulders down for clearance when treating lateral fields to the neck.

The recall was initiated because the wool wrist loops were manufactured 7cm shorter than the product specifications. The affected lot is M612690.

The products were distributed worldwide, including in the United States to the states of Arizona, Missouri, Pennsylvania, and Wisconsin, as well as in Austria, India, and Japan. Users should stop using the affected wrist loops and contact Med Tec Inc for instructions on return or replacement.

The recalled product

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.
Manufacturer
Med Tec Inc
Affected units
11

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot: M612690 REF: 20SR02SUB2

Distribution

Distributed in 4 states:

Part of a larger recall action

This product is one of 2 recalled by Med Tec Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →