Z-1260-2011

Ethicon SecureStrap 5 mm Absorbable Strap Fixation Device Product Code STRAP25. Intended for fixation of...

Name: Z-1260-2011 Ethicon SecureStrap 5 mm Absorbable Strap Fixation Device Product Code STRAP25. Intended for fixation of...
Creator: Ethicon, Inc.
Published: 2010-12-29
License: https://open.fda.gov/license/

Ethicon, Inc / initiated 2010-12-29 / Terminated / root cause: packaging

FDA source

Ethicon, Inc. began a recall of Ethicon SecureStrap 5 mm Absorbable Strap Fixation Device Product Code STRAP25. Intended for fixation of prosthetic material to soft tissues in various... on 2010-12-29. The reason FDA records is "The Ethicon SecureStrap 5 mm Absorbable Strap Fixation Device may have the potential for the sterile barrier to be compromised due to a defect in the packaging". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1260-2011
Status: Terminated
Initiated: 2010-12-29
Posted: 2011-02-18
Terminated: 2012-11-07
Recalling firm: Ethicon, Inc
Product: Ethicon SecureStrap 5 mm Absorbable Strap Fixation Device Product Code STRAP25. Intended for fixation of prosthetic material to soft tissues in various minimally invasive and open surgical procedures, such as hernia repairs.
Product code: GDW Staple, Implantable
Reason for recall: The Ethicon SecureStrap 5 mm Absorbable Strap Fixation Device may have the potential for the sterile barrier to be compromised due to a defect in the packaging.
Root cause tag: packaging
FDA root cause: Pending
Action: Ethicon sent Urgent Voluntary Product Recall letters dated, December 28, 2010, to their customers on December 29, 2010 via UPS. The letter identified the affected product and described the reason for recall. Customers are to discontinue use and sampling immediately. They are to return the product using the enclosed prepaid shipping label along with the enclosed business reply card regardless of whether they have any affected product or not. Customers should contact 1-877-551-7147 or speak to their manager if they have questions regarding this recall.
Quantity in commerce: 4,110
Distribution: Worldwide Distribution -- USA and Canada.
Product codes and lots: All Lots. Batch Numbers: CJM838,CJZ014, CJZ065, CJZ228, CJZ456, CJZ542, CJZ625, CJ6116, CJ6293, CJ6402, CJ6572, CJ6852, CJK043, CJK216, CJK330, CJK536, CJK659, CKM791, CKZ068, CKZ437, CKZ652, and CK6002.

Product code GDW

K093845Class IIEthicon Securestrap 5Mm Absorbable Strap Fixation Device, Model Strap25ETHICON, Inc. / cleared 2010-04-07

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)