FDA Medical Device Recalls (openFDA)
Mako Surgical Corporation: Stryker Restoris RIO Reamer Handle, Offset, Mako Rx only Product Usage: The handle is used to hold surgical components during acetabular reaming in MAKO Total Hip procedures.
- Recall number
- Z-1193-2017
- Recalling firm
- Mako Surgical Corporation
- Product
- Stryker Restoris RIO Reamer Handle, Offset, Mako Rx only Product Usage: The handle is used to hold surgical components during acetabular reaming in MAKO Total Hip procedures.
- Status
- Terminated
- Initiated
- 2016-09-29
- Posted
- not on file
- Terminated
- 2019-08-06
- Reason
- Failure of the Offset Cup Reamer Handle not engaging its mating components.
- Root cause
- Component change control
- Action
- Customers were sent a recall notificaiton letter, dated 10/17/2016, addressing the reason for recall and the appropriate actions that should be taken by customers. Consignees are instructed to return any recalled product on hand to Stryker C/O Stericycle, 2670 Executive Dr. Suite A, Indianapolis, IN 46241, Attn RA 2016-083, RA 2016-119 - Event 8811. Consignees are also instructed to inform their users of this recall and forward the notice to affected individuals. A Business Reply Form was provided and is to be completed within 5 business days of receipt by consignees. Completed business reply forms are to be faxed to 855-620-5693 or emailed to strykerortho8811@stericycle.com.
- Quantity
- 595 units
- Distribution
- Worldwide Distribution - US Nationwide in the states of AL, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NH, NJ, NM, NY, OH, OK, OR, PA, RI, TN, TX, UT, VA, WA, WI, WV, & WY and the countries of Italy, Germany, Australia, China, Europe, Hong Kong, South Africa, Germany, Thailand & Singapore.
- Lot, serial or model codes
- All lots recalled, Catalog No. 207080.
- 510(k) numbers
- ["K121064"]
- PMA numbers
- not on file
- Product code
- OLO
- Firm FEI
- 3005985723
- Firm city
- Davie
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28