Z-0178-2012

LifeCell Strattice Reconstructive Tissue Matrix for Stoma Reinforcement Catalog #0606008 (6 x 6 cm), 0808008...

Name: Z-0178-2012 LifeCell Strattice Reconstructive Tissue Matrix for Stoma Reinforcement Catalog #0606008 (6 x 6 cm), 0808008...
Creator: LifeCell Corporation
Published: 2011-07-13
License: https://open.fda.gov/license/

LifeCell Corp / initiated 2011-07-13 / Terminated

FDA source

LifeCell Corporation began a recall of LifeCell Strattice Reconstructive Tissue Matrix for Stoma Reinforcement Catalog #0606008 (6 x 6 cm), 0808008 (8 cm x 8 cm), (0610008 ( 6 cm x 10 cm). Intended... on 2011-07-13. The reason FDA records is "The use of Strattice for stoma reinforcement at the time of stoma creation is not within the product's cleared indications for use in the US market". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0178-2012
Status: Terminated
Initiated: 2011-07-13
Posted: 2011-11-09
Terminated: 2013-03-04
Recalling firm: LifeCell Corp
Product: LifeCell Strattice Reconstructive Tissue Matrix for Stoma Reinforcement Catalog #0606008 (6 x 6 cm), 0808008 (8 cm x 8 cm), (0610008 ( 6 cm x 10 cm). Intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes.
Product code: FTM Mesh, Surgical
Reason for recall: The use of Strattice for stoma reinforcement at the time of stoma creation is not within the product's cleared indications for use in the US market.
FDA root cause: PMA
Action: LifeCell began notifying their customers via phone on 7/13/2011. Recall Notice Letters and return response forms, dated July 12, 2011, were sent out on the same day. The letter identified the affected product and informed customers of the reason for the recall. Customers were asked to examine their inventory and quarantine the affected product. If customers have affected product, they were to contact Customer Solutions at 1-866-423-2433 to arrange for return of the product to LifeCell. Also, the attached Recall Notification form should have been completed and returned no later than August 17, 2011. Questions should be directed to Customer Solutions at 1-866-423-2433.
Quantity in commerce: 2651 sublots (of 42 lots)
Distribution: Nationwide Distribution
Product codes and lots: The following lots begin with the letter 'S' 10664; 10665; 10666; 10667; 10668; 10670; 10671; 10672; 10678; 10679; 10680; 10683; 10684; 10685; 10686; 10688; 10689; 10690; 10691; 10698; 10700; 10701; 10702; 10777; 10778; 10780; 10838; 10844; 10845; 10847; 10848; 10851; 10863; 10864; 10866; 10867; 10871; 10872; 10875; 10877; 10896; and 10910.

Product code FTM

K070560Class IILrtm Surgical MeshLifecell Corp. / cleared 2007-06-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)