28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-122
Recall
- Recall Number
- Z-0314-2022
- Event Number
- 88964
- Firm
- Howmedica Osteonics Corp.
- FEI Number
- 3003070421
- Product Code
- JDG
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- October 15, 2021
- Address
- 325 Corporate Dr, Mahwah, NJ, 07430-2006
Description
28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-122
There is a potential for the outer white Tyvek lid to debond from the sealed package.
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
Puerto Rico