Z-1501-06

Neoligaments Staple Impactor, 8 mm Staple Impactor: 202-3010

Name: Z-1501-06 Neoligaments Staple Impactor, 8 mm Staple Impactor: 202-3010
Creator: Xiros Plc
Published: 2006-05-17
License: https://open.fda.gov/license/

Xiros Ltd / initiated 2006-05-17 / Terminated / root cause: sterility

FDA source

Xiros Plc began a recall of Neoligaments Staple Impactor, 8 mm Staple Impactor: 202-3010 on 2006-05-17. The reason FDA records is "The impactors are being recalled for modification so that they can be disassembled fully for cleaning and sterilization, on suspicion that the assembled items retain contamination after cleaning and may not be...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-1501-06
Status: Terminated
Initiated: 2006-05-17
Posted: 2006-09-13
Terminated: 2012-09-14
Recalling firm: Xiros Ltd
Product: Neoligaments Staple Impactor, 8 mm Staple Impactor: 202-3010
Product code: HXJ Staple Driver
Reason for recall: The impactors are being recalled for modification so that they can be disassembled fully for cleaning and sterilization, on suspicion that the assembled items retain contamination after cleaning and may not be effectively sterilized by the recommended hospital sterilization cycles.
Root cause tag: sterility
FDA root cause: Other
Action: Customer recall notifications included: a) Telephone notification to highest volume users b) Recall letters were sent via certified mail to all customers June 1, 2006. Customers were instructed to cease using immediately and return the Impactors to Tapco. The customers were instructed to call the firm for a return authorization number. Modified loaner Impactors will be made available to customers as soon as possible.
Quantity in commerce: 10, none distributed in US
Distribution: Nationwide & Worldwide, including Spain, Japan, UAE, Italy, Germany
Product codes and lots: N/A

Product code HXJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)