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

FDA device recall Z-2745-2020 · posted 2020-07-31 · Terminated

Recall details

Recalling firm

Mako Surgical Corporation

Reason for recall

Characterization issue associated with the product. This issue may cause a discrepancy during bone preparation in certain Mako Total Hip procedures.

Action taken

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

Root cause

Under Investigation by firm

Status

Terminated

Product code

OLO

Quantity affected

12 units

Distribution

TX, MN, CA, RI, FL, NY, AZ, TN

Date initiated

2020-07-09

Date posted

2020-07-31

Date terminated

2023-06-16

Location

Davie, FL

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