Implantech Associates Inc: Medical Device Recall in 2014 - (Recall #: Z-1063-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: January 29, 2014

Date Posted: February 26, 2014

Recall Number: Z-1063-2014

Event ID: 67446

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.

Status: Terminated

Product Quantity: 300

Code Information:

Catalog Number SLV634, Lot Number 852766.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated