—#162926

Product

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 product code: MBH — Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K141056
Affected lot / code info: Catalog 5521-B-300, lot code ATV7IA Catalog 5521-B-400, lot code ATY40A

Why it was recalled

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

Root cause (FDA determination)

Error in labeling

Action the firm took

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.

Recalling firm

Firm: Howmedica Osteonics Corp.
Address: 325 Corporate Dr, Mahwah, New Jersey 07430-2006

Distribution

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

Timeline

Recall initiated: 2018-01-12
Terminated: 2020-05-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #162926. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.