FDA Medical Device Recalls (openFDA)
Medacta Usa Inc: Medacta GMK HINGE, Tibial Insert Fixed, SIZE 2, HEIGHT 23 mm, REF 02.09.0223H, STERILE EO
- Recall number
- Z-2661-2017
- Recalling firm
- Medacta Usa Inc
- Product
- Medacta GMK HINGE, Tibial Insert Fixed, SIZE 2, HEIGHT 23 mm, REF 02.09.0223H, STERILE EO
- Status
- Terminated
- Initiated
- 2017-05-19
- Posted
- 2017-06-12
- Terminated
- 2018-05-29
- Reason
- One lot of product does not include a screw for attachment to the tibial base plate.
- Root cause
- Nonconforming Material/Component
- Action
- On 5/19/17 all distributors with recalled product were immediately notified of the recall by email. On 5/23/17, all distributors were further notified of the recall via phone. On 5/30/17, a third notification was completed via phone.
- Quantity
- 4 units
- Distribution
- CA, AZ, NC, Israel, France
- Lot, serial or model codes
- Lot # 163646
- 510(k) numbers
- ["K130299"]
- PMA numbers
- not on file
- Product code
- KRO
- Firm FEI
- 3006639916
- Firm city
- Memphis
- Firm state
- TN
- 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