RecallRadar

FDA Device recall Z-0906-2015

Optetrak Asymmetric Hi-Flex Posterior Stabilized Cemented Femorals, size 3, Catalog #244-02-03, Catalog #244-03-03

On 2015-01-14 the FDA classified a Class II recall of Optetrak Asymmetric Hi-Flex Posterior Stabilized Cemented Femorals, size 3, Catalog #244-02-03, Catalog #244-03-03 by Exactech, citing mislabeled.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0906-2015
ClassificationClass II
Statusterminated
Initiated2014-10-09
Published2015-01-14
Last updated2026-09-13 11:53 UTC
CompanyExactech
Distributionn/a

Product

Optetrak Asymmetric Hi-Flex Posterior Stabilized Cemented Femorals, size 3, Catalog #244-02-03, Catalog #244-03-03. Usage:Femoral implants

Reason

Mislabeled

Identifiers

code_infoCatalog #244-02-03, Serial # 2925147 - 2925194; Catalog #244-03-0, Serial #2925246 - 2925293.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0906-2015%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.