FDA Medical Device Recalls (openFDA)
Medacta Usa: GMK Hinge knee prosthesis; Model Number: 02.09.TA410; Orthopedics and Orthopedic Surgery
- Recall number
- Z-0275-2016
- Recalling firm
- Medacta Usa
- Product
- GMK Hinge knee prosthesis; Model Number: 02.09.TA410; Orthopedics and Orthopedic Surgery
- Status
- Terminated
- Initiated
- 2015-04-17
- Posted
- 2015-11-14
- Terminated
- 2017-01-05
- Reason
- Incorrect parts: Packages of the GMK Hinge Tibial Augmentation size 4-10 mm have 5 mm screws instead of 10 mm screws.
- Root cause
- Employee error
- Action
- On 4/16/15 all distributors with recalled product were immediately notified of the recall by phone. On 4/20/15, all distributors were further notified of the recall via email. The URGENT MEDICAL DEVICE RECALL letter dated 4/17/2015 the firm described the initiation of a recall for regarding the GMK HINGE Tibial Augmentation Size 4-10mm Reference 02.09TA410 / Lot 145129. The firm provided the following recall actions to be performed: 1.Check your inventory for the device listed above. If you find it, IMMEDIATELY place it in quarantine and DO NOT use it in surgery. 2.If you have further distributed this device to other customers please notify me and initiate their return to Medacta USA. 3.We will provide you with an update on a replacement within the next few days. The firm also provided a contact for customers requiring additional information. Mike Loiterman Director of Regulatory, Quality and Compliance Medacta USA Phone: 312548-9971Fax: 312-546-6881MLoiterman@medacta.us.com
- Quantity
- 4 units (US)
- Distribution
- Distributed in the states of IL, OH and UT, and the countries of in Austria, Spain, Australia, France and Switzerland.
- Lot, serial or model codes
- Lot: 145129
- 510(k) numbers
- ["K130299"]
- PMA numbers
- not on file
- Product code
- KRO
- Firm FEI
- 3015500078
- Firm city
- Chicago
- Firm state
- IL
- 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