32MM -4 V40 TAPER VIT HEAD, Catalog Number 6260-5-032
- Company
- Howmedica Osteonics Corp.
- Recall Initiated
- December 21, 2021
- Recall Number
- Z-0644-2022
- Quantity
- 8 units
- Firm Location
- Mahwah, NJ
Reason for Recall
There is a potential for the outer Tyvek lid to de-bond from the sealed package.
Distribution
Worldwide distribution - US Puerto Rico and the countries of Canada, and Malaysia.
Lot / Code Info
UDI: 07613327012842; Lot Number: 87327407
Root Cause
Under Investigation by firm
Action Taken
An URGENT MEDICAL DEVICE RECALL UPDATE notification letter dated 12/21/21 was sent to customers. Recommendations for Patient Follow-Up Patients should continue to be followed per the normal protocol established by his/her surgeon. There are no recommended changes to the frequency of the standard follow-up care protocol. Actions Needed Our records indicate that you may have received the affected product(s). It is Stryker s responsibility as the manufacturer to ensure that customers who may have received these affected products also receive this important follow up communication. We therefore request that you read this notice carefully and complete the following actions. 1. Please inform users of this Urgent Medical Device Recall UPDATE 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. Complete and sign the enclosed Urgent Medical Device Recall UPDATE Business Reply Form 5. 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 UPDATE to the individuals or organizations who have consigned product, if applicable. Return all affected devices available at your location to the following address. Att. Regina Short (Quality Manager) / PFA# 2812588 Stryker Global Quality & Operations Tullagreen Building, IDA Business & Technology Park, Carrigtwohill, Cork, Ireland T45 HE42 Please assist us in meeting our regulatory obligation by faxing back the attached Urgent Medical Device Recall UPDATE Business Reply Form within 5 days. A response is required, even though you may not have any physical inventory on site. We regret any