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U.S. Department of Health and Human Services

Class 2 Device Recall Mako Integrated Cutting System (MICS) Handpiece

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 Class 2 Device Recall Mako Integrated Cutting System (MICS) Handpiecesee related information
Date Initiated by FirmAugust 07, 2024
Date PostedOctober 09, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0044-2025
Recall Event ID 95277
510(K)NumberK093425 
Product Classification Orthopedic stereotaxic instrument - Product Code OLO
ProductMAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
Code Information GTIN: 00848486030193; Serial Numbers: 4200075 4200134 4200177 4200179 4200191 4200234 4200235 4200251 4200339 4200351 4200359 4200387 4200427 4200461 4200510 4200515 4200531 4200602 4200608 4200611 4200639 4200641 4200648 4200650 4200653 4200671 4200697 4200709 4200712 4200729 4200734 4200757 4200850 4200856 4200868 4200873 4200898 4200902 4200966 4201034 4209747 4209750 4209781 4209789 4209803 4209821 4209864 4209866 4209878 4209882 4209899 4209900 4209950 4209955 4209967 4210004 4210033 4210039 4210051 4210086 4210092 4210098 4210167 4210211 4210213 4210220 4210265 4210267 4210325 4210329 4210359 4210408 4210418 4210439 4210445 4210455 4210503 4210505 4210509 4210522 4219193 4219267 4219400 4219446 4219535 4219682 4219702 4219881 4220005 4220154 4220230 4220237 4220263 4220451 4220452 4220810 4220836 4221090 4221102 4221103 4221106 4221243 4221268 4221335 4221462 4221471 4221563 4221685 4221808 4222927 4222994 4222995 4222996 4222997 4222998 4222999 4223000 4223001 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FEI Number 3003070421
Recalling Firm/
Manufacturer		 Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430-2006
Manufacturer Reason
for Recall		Stryker has identified an issue with the characterization process that impacted the constant values assigned to the associated MICS Handpieces.
FDA Determined
Cause 2		Vendor change control
ActionAn URGENT MEDICAL DEVICE RECALL notification letter dated 8/7/24 was sent to customers. Recommendations for patients treated with an impacted device: Patients treated with an affected product identified in Attachment 1 should continue to be followed per the normal protocol established by his or her surgeon(s). 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 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 and forward this notice to all individuals who need to be made aware or organizations who have consigned product. 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 in Table 1. 4. Complete and sign the enclosed Urgent Medical Device Recall Business Reply Form and email to " Medical Facility: Please sign the Business Reply Form and email to: strykerortho3291@sedgwick.com/ Fax: (800) 871-7270 5. Please contact your Local Sales Office or your Stryker Sales Representative directly for product replacement and inventory questions. 6. Please return the devices to Stryker using the following address: Stryker Orthopaedics/PFA Product Returns Attn: Distribution Inventory Team 3365 Enterprise Avenue Weston, Florida, 33331 Ref. PFA 3626925(Please provide tracking number) Please assist us in meeting our regulatory obligation by completing and emailing the attached Urgent Medical Device Recall Business Reply Form within 5 days. A response is required, even though you may not have any physica
Quantity in Commerce897 units
DistributionWorldwide distribution - US Nationwide and the countries of Australia, Germany.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = OLO
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