FDA Medical Device Recalls (openFDA)
Stryker Howmedica Osteonics Corp.: LFIT Anatomic V40 Femoral Head, Low Friction Ion Treatment, Sterile, 36 mm, REF 6260-9-236; Modular components designed to be locked onto a femoral hip stem trunnion during surgery for total hip replacement.
- Recall number
- Z-0378-2017
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Product
- LFIT Anatomic V40 Femoral Head, Low Friction Ion Treatment, Sterile, 36 mm, REF 6260-9-236; Modular components designed to be locked onto a femoral hip stem trunnion during surgery for total hip replacement.
- Status
- Terminated
- Initiated
- 2016-08-29
- Posted
- not on file
- Terminated
- 2017-05-02
- Reason
- Stryker received several complaints describing incidence of harm secondary to taper lock failure for specific lots of numerous catalog numbers of LFIT Anatomic CoCr V40 Femoral Heads.
- Root cause
- Under Investigation by firm
- Action
- Stryker notified their Branches/Agencies of this recall by e-mail on August 29, 2016 and they were asked to quarantine the affected devices. A Recall Notification Letter and Product Accountability Form was also sent on August 29, 2016 via UPS (with return receipt) to their Branches/Agencies/Hospital Risk Management and Surgeons. On October 11, 2016, Stryker sent an updated recall notification via UPS with return receipt to their affected customers because additional customers and lot numbers were identified.
- Quantity
- 42,519 units (total Catalog numbers)
- Distribution
- US Nationwide and Internationally
- Lot, serial or model codes
- Catalog #6260-9-236 - Head Diameter 36 mm, Offset +5, including all lots manufactured from 1/102 - 7/1/10; Catalog #6260-9-240 - Head Diameter 40 mm, Offset +4, including all lots manufactured from 1/1/06 - 3/4/11; Catalog #6260-9-244 - Head Diameter 44 mm, Offset +4, including all lots manufactured from 1/1/06 - 3/4/11; Catalog #6260-9-340 - Head Diameter 40 mm, Offset +8, including all lots manufactured from 1/1/06 - 3/4/11; Catalog #6260-9-440 - Head Diameter 40 mm, Offset +12, including all lots manufactured from 1/1/06 - 3/4/11; Catalog #6260-9-344 - Head Diameter 44 mm, Offset +8, including all lots manufactured from 1/1/07 - 3/4/11 and Catalog #6260-9-444 - Head Diameter 44 mm, Offset +12, including all lots manufactured from 1/1/06 - 3/4/11.
- 510(k) numbers
- ["K022077"]
- PMA numbers
- not on file
- Product code
- JDI
- Firm FEI
- 3003070421
- Firm city
- Mahwah
- Firm state
- NJ
- 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