Data Foundry

Medical device recalls 2017

CIVCO Arm Support — Class II medical device recall Z-3083-2017

Terminated recall by Med Tec Inc, reported 2017-09-06, distributed in IL, MI, TX. Rigid Arm Supports (PN: 106015 and 106047), which were used as part of the Posiboard-2 and Posirest, and were

Recall numberZ-3083-2017
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmMed Tec Inc, Orange City, IA, United States
Recall initiated2017-08-10
Classified2017-08-29
Reported by FDA2017-09-06
Terminated2024-03-19
DistributedIL, MI, TX
Countries outside the USAT, AU, BD, BR, CH, CZ, DE, FR, GB, GR, HR, HU, IL, IT, JP, LK, NO, PK, PL, SI
Quantity30 units
Model numbers106047

Product

CIVCO Arm Support, REF 106047, distributed as: (a) Rigid Arm Support, Large, Set, Red (PN: 106047) (b) PB2-BDLRL (PN: 109040) (c) Rigid Adj. Arm Support, Large, Set (PN: 106048) (d) PSR2-CF-DLRL-2P Posirest-2 (PN: 106522) The Rigid Arm Supports are utilized on the Posibboard2 and Posirest assemblies, which are intended to position the patients upper extremities during breast and lung diagnostic and radiotherapy treatment.

Reason for recall

Rigid Arm Supports (PN: 106015 and 106047), which were used as part of the Posiboard-2 and Posirest, and were distributed as PN: 106015, 106047, 106521, 106522, 109030, and 109040 between Ocotober 2009 and July 2012 may have a height difference of approximately 17mm.

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-3083-2017. 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.