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Terminated

Knee Prosthesis, Sterile, Single-Use devices Product Usage: The knee system devices are intended for use in revision total knee arthroplasty to alleviate pain and restore function

FDA Recall Z-1512-2018 · Posted None

Recalling FirmHowmedica Osteonics Corp.
Recall StatusTerminated
Product CodeMBH
Date Initiated2018-01-12
Date Terminated2020-05-07
Product Quantity6 units of catalog 5521-B-400

Reason for Recall

Firm became aware that the specific product/lot combinations referenced above may contain the incorrect size implant from what is labeled on the box.

Firm Action

Branches/Agencies notified by email on 01/16/2018 and were asked to quarantine affected devices. Notification letters and product accountability forms were sent via UPS (with return receipt) on 01/15/2018. Customer notifications were updated and sent to consignees on 03/16/2018 as the technical and medical assessments associated with the issue were completed and additional information related to potential hazards and harms were identified.

Root Cause

Error in labeling

Distribution Pattern

Affected products were sent to three medical facilities. Affected product will be returned to the manufacturer for disposition.

Official Source

View FDA Recall →

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

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