MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
Recall
- Recall Number
- Z-0044-2025
- Event Number
- 95277
- Firm
- Howmedica Osteonics Corp.
- FEI Number
- 3003070421
- Product Code
- OLO
- Status
- Open, Classified
- Root Cause
- Vendor change control
- Initiated
- August 7, 2024
- Posted
- October 9, 2024
- Address
- 325 Corporate Dr, Mahwah, NJ, 07430-2006
Description
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
Stryker has identified an issue with the characterization process that impacted the constant values assigned to the associated MICS Handpieces.
An 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: [email protected]/ 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
Worldwide distribution - US Nationwide and the countries of Australia, Germany.
897 units