Adjustable Gastric Band, packaged alone in transparent PETG inner and outer blisters with Tyvek lids, or in various kit

FDA device recall Z-0149-2014 · posted 2013-11-05 · Terminated

Recall details

Recalling firm

Ethicon Endo-Surgery Inc

Reason for recall

During aging studies, the firm determined that the gastric belts were unable to pass the test requirements established for Force to Lock.

Action taken

Ethicon sent an Urgent: Medical Device Recall letter dated September 30, 2013 to affected consignees via overnight, UPS to allow tracking of the receipt. The letter identified affected products, problem and actions to be taken. Each consignee is requested to respond to a provided Business Reply Form (BRF), indicating whether they have affected product, how much and whether they will/have returned the product or whether they no longer have any of the recall product. For questions contact your local sales representative or call our Customer Support Center 1-877-384-4266 option 6.

Root cause

Unknown/Undetermined by firm

Status

Terminated

Product code

LTI

Quantity affected

Product codes: RLZB22 - 2,352 units; RLZB22D1 - 968 units; RLZB22DG1 - 327 units; RLZB22DGT - 20 units; RLZB22DT - 48 units; RLZB22T - 0 units

Distribution

Worldwide Distribution: USA (nationwide) including the states of: Alabama, Connecticut, Indiana, Michigan, North Carolina, South Carolina, Alaska, Delaware, Kansas, Minnesota, Ohio, Tennessee, Arizona

Date initiated

2013-09-30

Date posted

2013-11-05

Date terminated

2014-03-26

Location

Cincinnati, OH