Ethicon SecureStrap 5 mm Absorbable Strap Fixation Device… recallZ-1260-2011 · Ethicon, Inc. · initiated Dec 29, 2010
Terminated All recalls posted in February 2011
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Ethicon, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Pending
What the company is doing
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.
Recall details
- Recall number
- Z-1260-2011
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Dec 29, 2010
- Posted by the FDA
- Feb 18, 2011
- Recalling firm
- Ethicon, Inc.
- Quantity
- 4,110
- Product code
- GDW
- FDA submissions
- K093845
- Distribution
- Worldwide Distribution -- USA and Canada.
Product description
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.
Code information (models, lots, serial numbers)
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.
Other devices under the same FDA submission
4 devices cleared under K093845 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- ETHICON SECURESTRAP STRAP25Ethicon, LLC · STAPLE, IMPLANTABLE329 reports
- ETHICON SECURESTRAP STRAP12Ethicon, LLC · STAPLE, IMPLANTABLE98 reports
- ETHICON SECURESTRAP STRAP25REthicon, LLC · Staple, implantable7 reports
- ETHICON SECURESTRAP STRAP12REthicon, LLC · Staple, implantable2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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