FDA Medical Device Recalls (openFDA)
Xiros Plc: Neoligaments Staple Impactor, 8 mm Staple Impactor: 202-3010
- Recall number
- Z-1501-06
- Recalling firm
- Xiros Plc
- Product
- Neoligaments Staple Impactor, 8 mm Staple Impactor: 202-3010
- Status
- Terminated
- Initiated
- 2006-05-17
- Posted
- 2006-09-13
- Terminated
- 2012-09-14
- Reason
- 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
- 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
- 10, none distributed in US
- Distribution
- Nationwide & Worldwide, including Spain, Japan, UAE, Italy, Germany
- Lot, serial or model codes
- N/A
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HXJ
- Firm FEI
- 3013299874
- Firm city
- Leeds
- Firm state
- not on file
- Firm country
- United Kingdom
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28