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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
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
- Hazard
- 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
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.
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