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U.S. Department of Health and Human Services

Class 2 Device Recall Mako Hip End Effector

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  Class 2 Device Recall Mako Hip End Effector see related information
Date Initiated by Firm July 09, 2020
Date Posted July 31, 2020
Recall Status1 Open3, Classified
Recall Number Z-2745-2020
Recall Event ID 86048
510(K)Number K141989  
Product Classification Orthopedic stereotaxic instrument - Product Code OLO
Product Mako Hip End Effector, Variable Angle
Catalog Number: 206967
GTIN:00848486022167
Code Information Serial Number 1905386; UDI (01)00848486022167(21)1905386 Serial Number 1905389; UDI (01)00848486022167(21)1905389 Serial Number 1905359; UDI (01)00848486022167(21)1905359 Serial Number 1905352; UDI (01)00848486022167(21)1905352 Serial Number 1905369; UDI (01)00848486022167(21)1905369 Serial Number 1905387; UDI (01)00848486022167(21)1905387 Serial Number 1905383; UDI (01)00848486022167(21)1905383   
Recalling Firm/
Manufacturer
Mako Surgical Corporation
2555 Davie Rd Ste 110
Davie FL 33317-7424
For Additional Information Contact Loriann Russo
201-831-5272
Manufacturer Reason
for Recall
Characterization issue associated with the product. This issue may cause a discrepancy during bone preparation in certain Mako Total Hip procedures.
FDA Determined
Cause 2
Under Investigation by firm
Action On July 09, 2020, Stryker's issued urgent medical device recall. The following actions were instructed in the recall notification. 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 Urgent Medical Device Recall Business Reply Form and fax a copy to 1-888-528-4543 or email to strykerorth8465@stericycle.com. 5.Hospitals Only: Please contact your Local Sales Office or your Stryker Sales Representative directly for product returns and inventory questions. 6.Branches/Agencies Only: Please forward the 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 2390692
Quantity in Commerce 7 units
Distribution TX, MN, CA, RI, FL
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 = OLO and Original Applicant = MAKO SURGICAL CORPORATION
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