FDA Medical Device Recalls (openFDA)
Smith & Nephew, Inc.: RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 16, REF 71369316, STERILE R, QTY: (1)
- Recall number
- Z-1912-2017
- Recalling firm
- Smith & Nephew, Inc.
- Product
- RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 16, REF 71369316, STERILE R, QTY: (1)
- Status
- Terminated
- Initiated
- 2017-03-30
- Posted
- not on file
- Terminated
- 2019-08-21
- Reason
- The stability data does not support the product labeled with a 10-year shelf life.
- Root cause
- Error in labeling
- Action
- The firm initiated their recall by email and letter on 03/30/2017. Consignees were asked to inspect inventory to locate and quarantine affected product. All consignees are asked to complete a Response Form provided with the Field Safety Notice, regardless whether they have affected product. Affected inventory is then to be returned back to Smith & Nephew.
- Quantity
- 1004 units
- Distribution
- Nationwide and Australia, Austria, Belgium, Canada, China, Colombia, Costa Rica, Denmark, Estonia, Finland, France, Great Britain, India, Italy, Japan, Mexico, Netherlands, Norway, Poland, Puerto Rico, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand, Trinidad & Tobago, United Arab Emirates, and Venezuela
- Lot, serial or model codes
- Batch numbers: 431604,431612,431614,448956,477931,484324,485498,488987,495483,450002910,4500029102, 4500031658,08CSY0044,08ESY0009,08ESY0010,08ESY0011,08JSY0034,08LSY0010,10CSY0008, 10ESY0014,11KSY0004,11KSY0024,12BSY0006,12BSY0014,12DSY0020,12HSY0009,12HSY0041, 12MSY0026,13BSY0032,13FSY0012,13FSY0023,13HSY0008,14BSY0015,14CSY0039,14GSY0025, 14KSY0003,15DSY0002,15FSY0020,15MSY0006,16BSY0010,477931B
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KDG
- Firm FEI
- 1020279
- Firm city
- Memphis
- Firm state
- TN
- 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