28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-028
FDA Recall Z-0313-2022 · Posted None
Recalling FirmHowmedica Osteonics Corp.
Recall StatusOpen, Classified
Product CodeJDG
Date Initiated2021-10-15
Reason for Recall
XXX
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
Root Cause
Under Investigation by firm
Distribution Pattern
Puerto Rico
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.