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U.S. Department of Health and Human Services

Class 2 Device Recall LFIT V40 HEAD

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  Class 2 Device Recall LFIT V40 HEAD see related information
Date Initiated by Firm October 15, 2021
Create Date November 30, 2021
Recall Status1 Open3, Classified
Recall Number Z-0313-2022
Recall Event ID 88964
510(K)Number K173499  
Product Classification Prosthesis, hip, femoral component, cemented, metal - Product Code JDG
Product 28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-028
Code Information UDI number - (01) 07613327012996(17)261913(10); lot numbers - 86953401, 86953503
Recalling Firm/
Manufacturer		 Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430-2006
For Additional Information Contact Rehad Gaffoor
201-831-5000
Manufacturer Reason
for Recall		 XXX
FDA Determined
Cause 2		 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
Distribution Puerto Rico
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = JDG and Original Applicant = Stryker Orthopaedics
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