MAKO RIO THA Application User Guides, for total hip arthroplasty, orthopedic surgery.
FDA Recall Z-1411-2017 · Posted None
Recalling FirmMako Surgical Corporation
Recall StatusTerminated
Product CodeOLO
Date Initiated2016-12-22
Date Terminated2019-08-06
Product Quantity777
Reason for Recall
Five (5) AFMEA Risk Control Measures are missing from the MAKO RIO THA Application User Guides
Firm Action
Letter from Stryker dated 1/28/2017 was sent via USP Next Day Air with return receipt to all their customers. With the following actions; Inform users of this medical device correction and forwar this notice to all those individuals who need to be aware within your organization and return the attached Business Replay Form within 5 business days, to Fax 844-782-5561 or via e-mail to [email protected]
Root Cause
Labeling design
Distribution Pattern
US nationwide distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.