FDA Medical Device Recalls (openFDA)
Mako Surgical Corporation: Stryker Mako Vizadisc Hip Procedure Tracking Kit
- Recall number
- Z-2925-2018
- Recalling firm
- Mako Surgical Corporation
- Product
- Stryker Mako Vizadisc Hip Procedure Tracking Kit
- Status
- Terminated
- Initiated
- 2018-07-24
- Posted
- 2018-08-24
- Terminated
- 2022-10-11
- Reason
- Specific lots of the Vizadisc Knee Procedure Tracking Kit and Vizadisc Hip Procedure Tracking Kit have the potential to be damaged on the Vizadisc reflective material causing an inability to be detected by the camera.
- Root cause
- Under Investigation by firm
- Action
- On about 07/24/2018, Stryker sent letters to all their consignees via URGENT MEDICAL DEVICE REMOVAL letter. Instructions for risk mitigation included to perform a visual inspection the discs during pre-surgery setup as the defect can be recognized due to apparent discoloration and in the event that a Vizadisc is damaged, risk may be mitigated by testing the Vizadiscs by attaching them to the probes and arrays during pre-surgery setup, as per Stryker's recommendations in "Surgical Technique Guide." This provides an opportunity for the user to show each instrument to the camera after assembly to confirm that all discs are detectable. Additional instructions included to inform all individuals of the recall within the organization, complete and return the enclosed Recall Notification Business Reply Form, and arrange for to return all affected devices to Stryker in Mahwah, NJ. On about 11/27/2018, Stryker initiated an expansion of the recall and notified customers via "UPDATE URGENT MEDICAL DEVICE REMOVAL" letter. Instructions are the same as in the original notification letter.
- Quantity
- 19,906 total devices
- Distribution
- All devices were distributed in the US in the following states: AK, AL, AR, AZ, CA, CO, CT, FL, IA, ID, KS, KY, LA, MA, MD, MI, MN, MO, NE, NC, NH, NJ, NY, NV, OH, PA, RI, SC, SD, TN. TX, UT, VA, WA, WI.
- Lot, serial or model codes
- Catalog Number 107130. Lot Numbers 17097K, 17124K, 17129K, 17136K, 17143K, 17103H. **EXPANSION** Lot Numbers 17007K, 17013K, 17024K, 17035K, 17054K, 16354H.
- 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