FDA Medical Device Recalls (openFDA)
Mako Surgical Corporation: 2.7 Degree Straight Sagittal Saw attachment (Mako Total Knee Application and Partial Knee Application 3.0)
- Recall number
- Z-1824-2019
- Recalling firm
- Mako Surgical Corporation
- Product
- 2.7 Degree Straight Sagittal Saw attachment (Mako Total Knee Application and Partial Knee Application 3.0)
- Status
- Terminated
- Initiated
- 2019-04-25
- Posted
- not on file
- Terminated
- 2021-04-22
- Reason
- The bearings of the saw attachments were ungreased.
- Root cause
- Under Investigation by firm
- Action
- On April 25, 2019, URGENT MEDICAL DEVICE RECALL letters under Stryker's letterhead were sent to their US consignees advising them of the issue, potential harm. This letter instructed their consignees to inform users of this device of the recall, requested that they complete the enclosed URGENT MEDICAL DEVICE RECALL BUSNESS REPLY FORM, and return all recalled product to Stryker. Actions to be taken by the Customer/ User: 1. Please inform users of this Urgent Medical Device Recall and forward this notice to all those individuals who need to be aware within your organization. 2. Hospitals/Branches/Agencies: Complete and sign the enclosed Urgent Medical Device Recall Business Reply Form and fax a copy to 1-877-496-5040 or email to Stryker10077@stericycle.com 3. Hospitals/Branches/Agencies: Return all affected instruments available at your location to the following address. Stryker Orthopaedics/PFA Product Returns Attn: Distribution Inventory Team 325 Corporate Drive Dock M-East Mahwah, NJ 07431 Ref. PFA 1958828
- Quantity
- 7
- Distribution
- AR, CA, FL, KS, MA, MO, NC, NJ, NY, OH, OR, TN, and TX. Australia, China and Netherlands
- Lot, serial or model codes
- Catalog Number: 212186 Lot Number: 35051018 and 35050918 UDI: (01)00848486032111(10)35051018 and (01)00848486032111(10)35050918
- 510(k) numbers
- ["K143752"]
- 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