Z-2661-2017Class II

Medacta GMK HINGE, Tibial Insert Fixed, SIZE 2, HEIGHT 23 mm, REF 02.09.0223H, STERILE EO

Name: Z-2661-2017 Medacta GMK HINGE, Tibial Insert Fixed, SIZE 2, HEIGHT 23 mm, REF 02.09.0223H, STERILE EO
Creator: Medacta Usa Inc
Published: 2017-05-19
License: https://open.fda.gov/license/

Medacta USA, Inc. / initiated 2017-05-19 / Terminated / root cause: manufacturing process

FDA source

Medacta Usa Inc began a recall of Medacta GMK HINGE, Tibial Insert Fixed, SIZE 2, HEIGHT 23 mm, REF 02.09.0223H, STERILE EO on 2017-05-19. FDA classified it as Class II and gives the reason as "One lot of product does not include a screw for attachment to the tibial base plate". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2661-2017
Classification: Class II
Status: Terminated
Initiated: 2017-05-19
Posted: 2017-06-12
Terminated: 2018-05-29
Recalling firm: Medacta USA, Inc.
Product: Medacta GMK HINGE, Tibial Insert Fixed, SIZE 2, HEIGHT 23 mm, REF 02.09.0223H, STERILE EO
Product code: KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Reason for recall: One lot of product does not include a screw for attachment to the tibial base plate.
Root cause tag: manufacturing process
FDA 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 in commerce: 4 units
Distribution: CA, AZ, NC, Israel, France
Product codes and lots: Lot # 163646

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2661-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2661-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-12	2017-07-03

Product code KRO

K130299Class IIGmk HingeMedacta International / cleared 2013-08-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)