FDA Medical Device Recalls (openFDA)
Implantech Associates Inc: Gelzone Shoulder Sleeve, Catalog Number SLV634, Lot Number 852766. Product Usage: To be used where limb support and/or elevation is considered necessary.
- Recall number
- Z-1063-2014
- 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.
- Status
- Terminated
- Initiated
- 2014-01-29
- Posted
- 2014-02-20
- Terminated
- 2015-03-12
- Reason
- 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
- 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
- 300
- Distribution
- Worldwide Distribution - USA (nationwide) in the states of: CA, AZ, IL, NC, CO and the country of: South Africa.
- Lot, serial or model codes
- Catalog Number SLV634, Lot Number 852766.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HST
- Firm FEI
- 1000142697
- Firm city
- Ventura
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28