Z-2745-2020Class II

Mako Hip End Effector, Variable Angle Catalog Number: 206967 GTIN:00848486022167

Name: Z-2745-2020 Mako Hip End Effector, Variable Angle Catalog Number: 206967 GTIN:00848486022167
Creator: Mako Surgical Corporation
Published: 2020-07-09
License: https://open.fda.gov/license/

Mako Surgical Corp. / initiated 2020-07-09 / Terminated

FDA source

Mako Surgical Corporation began a recall of Mako Hip End Effector, Variable Angle Catalog Number: 206967 GTIN:00848486022167 on 2020-07-09. FDA classified it as Class II and gives the reason as "Characterization issue associated with the product. This issue may cause a discrepancy during bone preparation in certain Mako Total Hip procedures". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2745-2020
Classification: Class II
Status: Terminated
Initiated: 2020-07-09
Posted: 2020-07-31
Terminated: 2023-06-16
Recalling firm: Mako Surgical Corp.
Product: Mako Hip End Effector, Variable Angle Catalog Number: 206967 GTIN:00848486022167
Product code: OLO Orthopedic Stereotaxic Instrument
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 root cause: 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 [email protected]. 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: 12 units
Distribution: TX, MN, CA, RI, FL, NY, AZ, TN
Product codes and lots: 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;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2745-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2745-2020	Class II	Terminated	Voluntary: Firm initiated	2020-08-12	2020-07-31

Product code OLO

K141989Class IIMakoplasty Total Hip Allpication, Rio Standard SystemMako Surgical Corporation / cleared 2014-11-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)