FDA Medical Device Recalls (openFDA)
Howmedica Osteonics Corp.: 28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-028
- Recall number
- Z-0313-2022
- Recalling firm
- Howmedica Osteonics Corp.
- Product
- 28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-028
- Status
- Open, Classified
- Initiated
- 2021-10-15
- Posted
- not on file
- Terminated
- not on file
- Reason
- XXX
- Root cause
- Under Investigation by firm
- Action
- On 10/15/2021, Stryker issued Urgent Medical Device Recall notices to customers. Actions Needed: 1. Please inform users of this Urgent Medical Device Recall and forward this notice to all individuals who need to be made aware. 2. Immediately check all stock areas and/or operating room storage to determine if any devices from the affected product list are at your facility. 3. Quarantine and discontinue use of the recalled devices identified in the affected product list. Return the devices back to Stryker. 4. Hospitals/Branches/Agencies: Complete and sign the enclosed Urgent Medical Device Recall Business Reply Form 5. Hospitals Only: Please contact your Local Sales Office or your Stryker Sales Representative directly for product returns and inventory questions. 6. Please forward this Urgent Medical Device Recall to the individuals or organizations who have consigned product, if applicable. Return all affected devices available at your location to the following address. Stryker Orthopaedics/PFA Product Returns Attn: Distribution Inventory Team 325 Corporate Drive Dock M-East Mahwah, NJ 07430 Ref. PFA 2812588
- Quantity
- not on file
- Distribution
- Puerto Rico
- Lot, serial or model codes
- UDI number - (01) 07613327012996(17)261913(10); lot numbers - 86953401, 86953503
- 510(k) numbers
- ["K173499"]
- PMA numbers
- not on file
- Product code
- JDG
- 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