FDA Medical Device Recalls (openFDA)
Smith & Nephew, Inc. Endoscopy Division: DYONICS POWER Shaver Blades, 4.5mm Long Full Radius, package of 3 Catalog Number: 7205341 Product Usage: Smith & Nephew DYONICS Disposable Endoscopic Blades are indicated for resection of soft and osseous tissues in both large and small articular cavities.
- Recall number
- Z-2732-2011
- Recalling firm
- Smith & Nephew, Inc. Endoscopy Division
- Product
- DYONICS POWER Shaver Blades, 4.5mm Long Full Radius, package of 3 Catalog Number: 7205341 Product Usage: Smith & Nephew DYONICS Disposable Endoscopic Blades are indicated for resection of soft and osseous tissues in both large and small articular cavities.
- Status
- Terminated
- Initiated
- 2011-05-06
- Posted
- 2011-07-01
- Terminated
- 2012-05-09
- Reason
- Product has insufficient weld between the shaft tube and tip, could result in the tip separating from the shaft tube during use.
- Root cause
- Process control
- Action
- Smith & Nephew notified customers by an "URGENT - PRODUCT RECALL 1st NOTIFICATION" letter dated May 6, 2011. The letter describes the product, problem, and actions to be taken. The letter asked customers to call 800-343-5717 (option 3) or send an email to endo.andreturn@smith-nephew.com for a Return Authorization (RA) Number to return product, obtain credit or order replacement blades. Customers are to complete the form and return to the address provided being sure to reference the RA number. For any questions regarding this recall customers were instructed to call 508-337-3731.
- Quantity
- 555 units
- Distribution
- Worldwide Distribution -- USA (nationwide) and countries of: Argentina, Australia, Brazil, Canada, Chile, China, Columbia, Germany, Hong Kong, Italy, Japan, Mexico, Netherlands, Turkey, and United Kingdom.
- Lot, serial or model codes
- Lot Number: 50561144
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HAB
- Firm FEI
- 3003604053
- Firm city
- Andover
- Firm state
- MA
- Firm country
- not on file
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