Med Tec Recalls Short Wool Wrist Loops for Shoulder Retractors
Med Tec Inc is recalling specific wool wrist loops for shoulder retractors because they 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 recall is for a dimensional manufacturing defect (7cm shorter than spec) with no reported injuries, illnesses, or safety hazards explicitly stated in the source text, fitting the criteria for cosmetic or minor defects.
Plain-English summary
Med Tec Inc is recalling the Civco MTSR03 Shoulder Retractor with Wrist Loops Kit, specifically the non-sterile re-usable wool wrist strap component. The recall involves Lot M612690, Reference 20SR03. The product is intended to pull patients' shoulders down for clearance when treating lateral fields to the neck.
The wool wrist loops were manufactured 7cm shorter than the product specifications. This dimensional deviation may affect the device's intended function or fit.
The affected units were distributed worldwide, including in the United States (Arizona, Missouri, Pennsylvania, and Wisconsin) and in Austria, India, and Japan. Users should stop using the affected wool wrist loops and contact Med Tec Inc for instructions on return or replacement.
The recalled product
- Product
- 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…
- Manufacturer
- Med Tec Inc
- Hazard
- Affected units
- 2
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: 20SR03
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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