Z-1063-2014Class II

Gelzone Shoulder Sleeve, Catalog Number SLV634, Lot Number 852766

Name: Z-1063-2014 Gelzone Shoulder Sleeve, Catalog Number SLV634, Lot Number 852766
Creator: Implantech Associates Inc
Published: 2014-01-29
License: https://open.fda.gov/license/

Implantech Associates Inc / initiated 2014-01-29 / Terminated / root cause: manufacturing process

FDA source

Implantech Associates Inc began a recall of Gelzone Shoulder Sleeve, Catalog Number SLV634, Lot Number 852766. Product Usage: To be used where limb support and/or elevation is considered necessary on 2014-01-29. FDA classified it as Class II and gives the reason as "Implantech initiated the voluntary recall of Gelzone Shoulder Sleever, SLV-634, Lot Number 852766 because it may not satisfy customer requirements for the robustness of the Velcro closure". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1063-2014
Classification: Class II
Status: Terminated
Initiated: 2014-01-29
Posted: 2014-02-20
Terminated: 2015-03-12
Recalling firm: Implantech Associates Inc
Product: Gelzone Shoulder Sleeve, Catalog Number SLV634, Lot Number 852766. Product Usage: To be used where limb support and/or elevation is considered necessary.
Product code: HST Apparatus, Traction, Non-Powered
Reason for recall: Implantech initiated the voluntary recall of Gelzone Shoulder Sleever, SLV-634, Lot Number 852766 because it may not satisfy customer requirements for the robustness of the Velcro closure.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Implantech sent a Recall Notification letters dated January 29, 2014 via mail and fax to the affected customers. The recall notification letter informed customers of the voluntary recall, product description with code information, reason for recall, contact information, and actions to be taken. The letter also contains a response section to be completed and returned via fax. For questions call 1-800-733-0833 x235.
Quantity in commerce: 300
Distribution: Worldwide Distribution - USA (nationwide) in the states of: CA, AZ, IL, NC, CO and the country of: South Africa.
Product codes and lots: Catalog Number SLV634, Lot Number 852766.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1063-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1063-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-26	2014-02-20

Product code HST

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)