FDA Medical Device Recalls (openFDA)
Mako Surgical Corporation: Stryker USB Converter, Polaris Spectra Camera, Catalog #201148, a component of the Mako Robotic-Arm Assisted Surgery System.
- Recall number
- Z-1735-2022
- Recalling firm
- Mako Surgical Corporation
- Product
- Stryker USB Converter, Polaris Spectra Camera, Catalog #201148, a component of the Mako Robotic-Arm Assisted Surgery System.
- Status
- Terminated
- Initiated
- 2022-08-08
- Posted
- not on file
- Terminated
- 2026-05-22
- Reason
- Certain units have the potential to exhibit infant failures whereby units either arrive non-functional, have the potential to become non-functional, or flash an error light while in use.
- Root cause
- Under Investigation by firm
- Action
- Stryker issued an "URGENT MEDICAL DEVICE CORRECTION" letter dated 8/8/2022 on the same date notifying their customers of a correction for the Mako System's USB Converter, Polaris Spectra Camera. The letter provided the issue, potential hazard, potential harm, risk mitigation, and actions needed. The actions included informing users of the medical device correction and forwarding the letter to all individuals who need to be aware within their organization. Complete and sign the enclosed Business Reply Form and email to SO_M_PRODUCT_FIELD_ACTION_RESPONSE@stryker.com within 5 days. The customer was informed Stryker will replace non-conforming USB Converter, Polaris Cameras, within the scope of the notification with qualified parts unaffected by the nonconformance. If you have any questions, please email:bradley.curtis@stryker.com.
- Quantity
- 2
- Distribution
- US Distribution was made to IL and AZ.
- Lot, serial or model codes
- Lot #22041607, UDI-DI (GTIN) 07613327407280.
- 510(k) numbers
- ["K121064"]
- PMA numbers
- not on file
- Product code
- OLO
- Firm FEI
- 3005985723
- Firm city
- Weston
- 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