RecallRadar

FDA Device recall Z-2661-2017

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

On 2017-07-12 the FDA classified a Class II recall of Medacta GMK HINGE, Tibial Insert Fixed, SIZE 2, HEIGHT 23 mm, REF 02.09.0223H, STERILE EO by Medacta Usa, citing one lot of product does not include a screw for attachment to the tibial base plate.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2661-2017
ClassificationClass II
Statusterminated
Initiated2017-05-19
Published2017-07-12
Last updated2026-09-13 11:54 UTC
CompanyMedacta Usa
DistributionAZ, CA, NC

Product

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

Reason

One lot of product does not include a screw for attachment to the tibial base plate.

Identifiers

code_infoLot # 163646

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2661-2017%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.