Z-2763-2015Class II

CIVCO Shoulder Retractors, Reusable non-sterile hand grip, REF 302070, packaged 1 set per box, RX. For use in...

Name: Z-2763-2015 CIVCO Shoulder Retractors, Reusable non-sterile hand grip, REF 302070, packaged 1 set per box, RX. For use in...
Creator: Med Tec Inc
Published: 2015-08-19
License: https://open.fda.gov/license/

Medtec LLC / initiated 2015-08-19 / Terminated / root cause: supplier

FDA source

Med Tec Inc began a recall of CIVCO Shoulder Retractors, Reusable non-sterile hand grip, REF 302070, packaged 1 set per box, RX. For use in patient positioning. The grips are used for... on 2015-08-19. FDA classified it as Class II and gives the reason as "The wrist straps used for positioning the patient are too long". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as supplier.

Recall record

Recall number: Z-2763-2015
Classification: Class II
Status: Terminated
Initiated: 2015-08-19
Posted: 2015-09-14
Terminated: 2016-10-07
Recalling firm: Medtec LLC
Product: CIVCO Shoulder Retractors, Reusable non-sterile hand grip, REF 302070, packaged 1 set per box, RX. For use in patient positioning. The grips are used for pulling down the shoulders during radiotherapy simulation and treatment sessions where opposed lateral fields are used in the neck area.
Product code: FMQ Restraint, Protective
Reason for recall: The wrist straps used for positioning the patient are too long
Root cause tag: supplier
FDA root cause: Vendor change control
Action: Med Tec Inc sent an Urgent Field Correction Notice dated August 18, 2015, via e-mail on August 19, 2015, and made phone calls on August 19, 2015, to all affected customers requesting return of the product. Customers were instructed to forward a copy of the notification letter to all customers who have received the product. Customers with questions were instructed to reach their representative by calling CIVCO Medical Solutions, adiation Oncology, at 800-842-8688 or 319-248-8688 between 8:00AM and 5:00PM CST. For questions regarding this recall call319-248-6502.
Quantity in commerce: 18 sets
Distribution: Worldwide Distribution - US including NE, SC, and KS. Foreign distribution was made to Australia, China, Venezuela, Spain, Turkey, and Hong Kong
Product codes and lots: Lot numbers M765570 and M784310.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2763-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2763-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-23	2015-09-14

Product code FMQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)