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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm December 21, 2021
Create Date February 16, 2022
Recall Status1 Open3, Classified
Recall Number Z-0644-2022
Recall Event ID 89456
510(K)Number K121308  
Product Classification Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
Product 32MM -4 V40 TAPER VIT HEAD, Catalog Number 6260-5-032
Code Information UDI: 07613327012842; Lot Number: 87327407
Recalling Firm/
Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430-2006
Manufacturer Reason
for Recall
There is a potential for the outer Tyvek lid to de-bond from the sealed package.
FDA Determined
Cause 2
Under Investigation by firm
Action 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
Quantity in Commerce 8 units
Distribution Worldwide distribution - US Puerto Rico and the countries of Canada, and Malaysia.
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 = LPH and Original Applicant = HOWMEDICA OSTEONICS CORP