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Terminated

Persona Partial Knee Spacer Blocks To assist in partial knee arthroplasty surgery

FDA Recall Z-1240-2018 · Posted None

Recalling FirmZimmer Biomet, Inc.
Recall StatusTerminated
Product CodeLXH
Date Initiated2017-10-24
Date Terminated2019-04-03
Product Quantity430

Reason for Recall

Zimmer Biomet is conducting a medical device recall for the Persona Partial Knee Spacer Blocks in sizes 8mm, 9mm, 10mm, 12mm, and 14mm. Complaints received indicated that flexion has the potential to feel tight during range-of-motion trialing and that the final trial has the potential to appear looser in extension.

Firm Action

The firm, Zimmer Biomet, sent an "URGENT MEDICAL DEVICE RECALL" letter dated 10/31/2017 to customers titled "Affected Product: Persona Partial Knee Spacer Blocks Size 8mm, 9mm, 10mm, 12mm, 14mm". The letter described the product, problem, and actions to be taken. The letter instructed customers to review the notification and ensure that affected personnel are aware of the contents. Review inventory for affected product which would then be quarantined and ultimately removed by a firm sales representative. The customers were also instructed to complete and return the Certificate of Acknowledgement Form (even if you do not have affected products at your facility) via email to: [email protected] or Fax to: 574-372-4265. If you have further questions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred to an on-call representative in the event of an emergency. Alternatively, your questions may be emailed to [email protected].

Root Cause

Component design/selection

Distribution Pattern

US Nationwide Distribution.

Official Source

View FDA Recall →

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

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