REALIZE Adjustable Gastric Band, Injection Port and Applier Product Code: RLZB22, RLZB22D, RLZB22DG Lot # ZHLBBB, ZHLBBC

FDA device recall Z-0289-2011 · posted 2010-11-02 · Terminated

Recall details

Recalling firm

Ethicon Endo-Surgery Inc

Reason for recall

The Tubing Strain Relief component of the Injection Port may detach from the Locking Connector, and migrate from its original position on the Locking Connector. This may result in: Tubing Strain Relief migrating on the Tubing; Kinking of the Tubing resulting in difficulty/inability to adjust the fluid volume within the Band; or a free foreign body in the abdominal wall or abdominal (peritoneal) ca

Action taken

Ethicon Endo-Surgery issued an Urgent : Devoced Recall Event 2240 letter dated October 8, 2010 to all consignees identifying the affected devices and actions to be taken. Consignees were instructed: DO NOTt use product from the affected lots, but implanted devices do not need to be removed as part of this recall. Examine inventory and remove the affected product. If they DO have the affected product, complete the Business Reply Form, keeping a copy for records, and place the original form in the box with the product to be returned, affix the pre-printed label, and return to Stericycle. If they DO NOT have the affected product, complete the Business Reply Form, and fax it to Stericycle. A redesigned replacement product will be sent out to consignees within 30-60 days of product return. Ethicon Endo-Surgery can be contacted at 513 337-8208 concerning this recall.

Root cause

Other

Status

Terminated

Product code

LTI

Quantity affected

23,538 pieces

Distribution

Worldwide Distribution: USA including the following states: AK, AL, AR, AZ, CA, CO, CT, Washington DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NV, N

Date initiated

2010-09-27

Date posted

2010-11-02

Date terminated

2011-11-18

Location

Cincinnati, OH