MAKO RIO THA Application User Guides, for total hip arthroplasty, orthopedic surgery.
This recall has been terminated (originally issued December 22, 2016).
- Company
- Mako Surgical Corporation
- Recall Initiated
- December 22, 2016
- Terminated
- August 6, 2019
- Recall Number
- Z-1411-2017
- Quantity
- 777
- Firm Location
- Davie, FL
- Official Source
- View on FDA website ↗
Reason for Recall
Five (5) AFMEA Risk Control Measures are missing from the MAKO RIO THA Application User Guides
Distribution
US nationwide distribution.
Lot / Code Info
Part Item #: 204863 - THA 1.0 Application User Guide Part Item #: 207116 - THA 2.0 Application User Guide Part Item #: 208692 - THA 2.1 Application User Guide Part Item #: 209711 - MAKOplasty THA Application User Guide Part Item #: 210555 - MAKIplast THA 3.1 Application User Guide Part Item#: 212026 - THA Application User Guide 2.1-2.1.1 THA 3.0, THA 3.1, 3.1.1 and 3.1.1.1 Part Item # 204863 THA 1.0 Application User Guide Part Item # 207116 THA 2.0 Application User Guide Part Item # 208692 THA 2.1 Application User Guide Part Item # 209711 MAKOplasty THA Application User Guide Part Item # 210555 MAKIplast THA 3.1 Application User Guide Part Item # 212026 THA Application User Guide
Root Cause
Labeling design
Action Taken
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 stykerortho4253@stericycle.com