Date Initiated by Firm | October 15, 2021 |
Create Date | November 30, 2021 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-0314-2022 |
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 6260-9-122 |
Code Information |
UDI number - (01) 07613327013016(17)261013(10);
lot numbers - 86604305, 86604306 |
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 | There is a potential for the outer white Tyvek lid to debond from the sealed package. |
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 |
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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.
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510(K) Database | 510(K)s with Product Code = JDG
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