FDA Medical Device Recalls (openFDA)
Smith & Nephew, Inc.: smith&nephew SMF(TM) STANDARD OFFSET STIKTITE(TM) COATED STEM 12/14 TAPER -1 SIZE, STEM, REF 713552510
- Recall number
- Z-1028-2019
- Recalling firm
- Smith & Nephew, Inc.
- Product
- smith&nephew SMF(TM) STANDARD OFFSET STIKTITE(TM) COATED STEM 12/14 TAPER -1 SIZE, STEM, REF 713552510
- Status
- Terminated
- Initiated
- 2019-02-19
- Posted
- not on file
- Terminated
- 2021-05-21
- Reason
- Complaints were received indicating that the outer label incorrectly identified the product as size "1" instead of "-1". The product contained within the package is size "-1"
- Root cause
- Packaging process control
- Action
- The firm notified its direct accounts by email and letter on 02/18/2019. The notice requested return of the recalled products. Distributors were directed to notify their customers of the recall and ensure that the actions are carried out.
- Quantity
- 58 units
- Distribution
- US: CA, TN, NC, AR, IN, FL, MO, and, Canada, China, France, Germany, Great Britain, India, Italy, Japan, Mexico, Poland, South Korea, Spain
- Lot, serial or model codes
- Batch Numbers: 11AM15163U, 11AM15184T, 11CM01097U, 15MM06466, 16EM13018, 16EM13035 & 18CM08027
- 510(k) numbers
- ["K103256"]
- PMA numbers
- not on file
- Product code
- LPH
- 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