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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 Effectorsee related information
Date Initiated by FirmJuly 09, 2020
Date PostedJuly 31, 2020
Recall Status1 Terminated 3 on June 16, 2023
Recall NumberZ-2745-2020
Recall Event ID 86048
510(K)NumberK141989 
Product Classification Orthopedic stereotaxic instrument - Product Code OLO
ProductMako Hip End Effector, Variable Angle Catalog Number: 206967 GTIN:00848486022167
Code Information UDI: (01)00848486022167(21)1905386; (01)00848486022167(21)1905389; (01)00848486022167(21)1905359; (01)00848486022167(21)1905352; (01)00848486022167(21)1905369; (01)00848486022167(21)1905387; (01)00848486022167(21)1905383; (01)00848486022167(21)1905353; (01)00848486022167(21)1905356; (01)00848486022167(21)1905357; (01)00848486022167(21)1905365; (01)00848486022167(21)1905388;
Recalling Firm/
Manufacturer		 Mako Surgical Corporation
2555 Davie Rd Ste 110
Davie FL 33317-7424
For Additional Information ContactLoriann 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
ActionOn 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 Commerce12 units
DistributionTX, MN, CA, RI, FL, NY, AZ, TN
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = OLO
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