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Terminated

MAKOplasty Hip Array Kit Laminate 150230

FDA Recall Z-1588-2016 · Posted None

Recalling FirmMako Surgical Corporation
Recall StatusTerminated
Product CodeOLO
Date Initiated2015-11-25
Date Terminated2016-08-25
Product Quantity10 units.

Reason for Recall

Stryker Orthpaedics became aware that there is the potential for the 210540 MAKOplasty Hip Array Kit Laminate 150230 to list two part numbers for the RIO Base Array, which is item #5 on the product table.

Firm Action

On 12/09/2015, Product Field Action Letters and Product Accountability forms were sent to Branch/Agencies via overnight courier with a return receipt; Hospital Risk Management were sent Notification letters and a Product Recall Acknowledgement form with return receipt on 12/9;/2015.

Root Cause

Component change control

Distribution Pattern

CO, KY, MN, WA and WV

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K121064MAKOPLASTY TOTAL HIP APPLICATION, RIO STANDARD SYSTEMMako Surgical Corporation · 2012-06-06

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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