FDA Medical Device Recalls (openFDA)
Smith & Nephew, Inc.: smith&nephew ANTHOLOGY POROUS HIGH OFFSET STEM, 12/14 TAPER, 7H SIZE, 32 MM x 112 MM, REF 71356107 Hip prosthesis.
- Recall number
- Z-1921-2018
- Recalling firm
- Smith & Nephew, Inc.
- Product
- smith&nephew ANTHOLOGY POROUS HIGH OFFSET STEM, 12/14 TAPER, 7H SIZE, 32 MM x 112 MM, REF 71356107 Hip prosthesis.
- Status
- Terminated
- Initiated
- 2018-05-02
- Posted
- 2018-05-09
- Terminated
- 2020-09-01
- Reason
- Three lots of Anthology HO Porous size 7 stems were manufactured with an undersized taper length. The device taper length was incorrectly manufactured as 0.393mm opposed to 0.442 mm.
- Root cause
- Process control
- Action
- The firm initiated the recall by letter on 05/02/2018. Consignees are asked to inspect inventory, locate and quarantine affected, unused devices. Affected product will be returned to Smith & Nephew. All consignees are asked to complete the Response Form, even if they do not have product to return. Distributors were directed to notify their customers of the field action and ensure that these actions are carried out. For further questions, please call (978) 749-1440
- Quantity
- 13 units
- Distribution
- US nationwide distribution.
- Lot, serial or model codes
- Lot Numbers: 17LM22019, 17LM10934, 17LM05900
- 510(k) numbers
- ["K052792"]
- PMA numbers
- not on file
- Product code
- JDI
- 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