Gelzone Shoulder Sleeve, Catalog Number SLV634, Lot Number 852766. Product Usage: To be used where limb support and/or e

FDA device recall Z-1063-2014 · posted 2014-02-20 · Terminated

Recall details

Recalling firm

Implantech Associates Inc

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.

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

HST

Quantity affected

300

Distribution

Worldwide Distribution - USA (nationwide) in the states of: CA, AZ, IL, NC, CO and the country of: South Africa.

Date initiated

2014-01-29

Date posted

2014-02-20

Date terminated

2015-03-12

Location

Ventura, CA