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Terminated

OrthoSensor VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Right, REF ZBH-PSNCREF311-R.

FDA Recall Z-0083-2019 · Posted None

Recalling FirmOrthosensor, Inc.
Recall StatusTerminated
Product CodeONN
Date Initiated2018-07-12
Date Terminated2019-06-27
Product Quantity37 devices

Reason for Recall

Some sensors were reported to have fluid inside the posterior lateral corner post-surgery.

Firm Action

Letters dated 7/12/2018 were either delivered by the sales representatives or issued via email to their consignees on 7/13/2018 explaining the reason for recall and requesting return of the devices, if still available, for replacement. The firm expanded the recall via letter dated 8/29/2018 for delivery by sales representatives or via sales representative email on 8/30/2018.

Root Cause

Under Investigation by firm

Distribution Pattern

Distribution was made CA, FL, IL, IN, MI, NY, and NC. Foreign distribution was made to Australia. There was no government/military distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K180459VERASENSE for Zimmer Biomet PersonaOrthosensor, Inc. · 2018-06-07

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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