Civco — Class II medical device recall Z-0989-2015
Terminated recall by Med Tec Inc, reported 2015-01-21, distributed in AZ, MO, PA, WI. The product (wool wrist loop) was manufactured 7cm shorter than product specifications.
| Recall number | Z-0989-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Med Tec Inc, Orange City, IA, United States |
| Recall initiated | 2014-12-11 |
| Classified | 2015-01-15 |
| Reported by FDA | 2015-01-21 |
| Terminated | 2017-02-03 |
| Distributed | AZ, MO, PA, WI |
| Countries outside the US | AT, IN, JP |
| Quantity | 11 |
| Lot numbers | M612690 |
| Model numbers | 20SR02SUB2 |
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.
Reason for recall
The product (wool wrist loop) was manufactured 7cm shorter than product specifications.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0989-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.