Z-1076-2015Class II

The SurgiWrap Bioresorbable Adhesion Barrier Film. SurgiWrap 100x130x0.05mm (01) 18964050255027 (17)...

Name: Z-1076-2015 The SurgiWrap Bioresorbable Adhesion Barrier Film. SurgiWrap 100x130x0.05mm (01) 18964050255027 (17)...
Creator: MAST Biosurgery USA, Inc
Published: 2014-08-26
License: https://open.fda.gov/license/

MAST Biosurgery USA, Inc / initiated 2014-08-26 / Terminated / root cause: labeling and UDI

FDA source

MAST Biosurgery USA, Inc began a recall of The SurgiWrap Bioresorbable Adhesion Barrier Film. SurgiWrap 100x130x0.05mm (01) 18964050255027 (17) 170731(10)52804 LOT 52804 2017-08 REF25502-01 Product is... on 2014-08-26. FDA classified it as Class II and gives the reason as "The expiration date of the bar code on the envelope label did not match the expiration date next to the hourglass. The printed expiration date was August of 2017, while the bar code date read as July 31, 2017. The...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1076-2015
Classification: Class II
Status: Terminated
Initiated: 2014-08-26
Posted: 2015-02-10
Terminated: 2015-02-24
Recalling firm: MAST Biosurgery USA, Inc
Product: The SurgiWrap Bioresorbable Adhesion Barrier Film. SurgiWrap 100x130x0.05mm (01) 18964050255027 (17) 170731(10)52804 LOT 52804 2017-08 REF25502-01 Product is wrapped in a foil pouch that is then sealed into an additional envelope.
Product code: FTL Mesh, Surgical, Polymeric
Reason for recall: The expiration date of the bar code on the envelope label did not match the expiration date next to the hourglass. The printed expiration date was August of 2017, while the bar code date read as July 31, 2017. The correct expiration date was July 31, 2017.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: MAST Biosurgery labeled 49 new envelopes and sent them to the distributor, and subsequently had the distributor remove the contents of the outer envelope (instructions for use and the foil pouches containing the product) and place them into the newly supplied and properly labeled outer envelopes provided by them. The distributor requested to send back the original 49 enveloped. The second batch of new labels was inspected and attached to the new outer envelope to create a properly labeled outer envelope prior to shipping. The firm requested that once the distributor replaced the product and the IFU into the newly labeled envelopes that they provide documentation that the product had been repackaged into the new envelopes. The distributor was also requested to verify that they did not ship any product to customers with the incorrect label. The firm had the distributor return the 49 improperly with the incorrect labels and the first set of "corrected" labels to them for destruction. Further questions call (858) 550-8050.
Quantity in commerce: 49 pieces
Distribution: Worldwide Distribution to the country of China.
Product codes and lots: LOT 52804 2017-08

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1076-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1076-2015	Class II	Terminated	Voluntary: Firm initiated	2015-02-18	2015-02-10

Product code FTL

K061473Class IISurgi-Wrap Mast Bioresorbable SheetMast Biosurgery USA, Inc. / cleared 2006-09-21

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)