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U.S. Department of Health and Human Services

Class 2 Device Recall stryker MAKO

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  Class 2 Device Recall stryker MAKO see related information
Date Initiated by Firm March 10, 2023
Date Posted April 12, 2023
Recall Status1 Open3, Classified
Recall Number Z-1385-2023
Recall Event ID 91913
510(K)Number K082172  K090763  
Product Classification Prosthesis, knee, femorotibial, non-constrained, cemented, metal/polymer - Product Code HSX
Product stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 5 RM/LL), REF 170615, intended for use in a Partial Knee Arthroplasty surgical procedure
Code Information GTIN 00848486003746, Lot Number 26270421
Recalling Firm/
Manufacturer		 Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430-2006
For Additional Information Contact Karina Strakhova Masullo
201-831-5000
Manufacturer Reason
for Recall		 Ccertain lots of the Restoris MultiCompartmental Knee (MCK) Tibial Baseplate Trials contain product with incorrect size laser marking
FDA Determined
Cause 2		 Process change control
Action Stryker issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 03/10/2023 by letter. The notice explained the issue and the hazard and requested the following actions be taken: 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 affected products in Table 1. 4. Complete and sign the enclosed Urgent Medical Device Recall Business Reply Form and email to strykerortho5321@sedgwick.com/ fax (888) 266-7910. 5. Please contact your Local Sales Office or your Stryker Sales Representative directly for product replacement and inventory questions. 6. Please return ALL affected product to: Stryker Orthopaedics/PFA Product Return. Stryker issued an URGENT MEDICAL DEVICE RECALL UPDATE notice to its consignees on 04/12/2023. The letter contained the same information, but added a section titled Recommendations for patients already treated with an affected device, and advised patients treated with an affected product should continue to be followed per the normal protocol established by his or her surgeon(s).
Quantity in Commerce 52 units
Distribution U.S., Netherlands, Japan, China, India, Korea, and Australia.
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 = HSX and Original Applicant = MAKO SURGICAL CORPORATION
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