Recalls / —
—#160230
Product
Persona Partial Knee System, Size 8, Finishing Guide
- FDA product code
- HSX — Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
- Device class
- Class 2
- Medical specialty
- Orthopedic
- 510(k) numbers
- K161592
- Affected lot / code info
- Item No. 42578100801, Lot No. 63518668, UDI (01)00880304809253(10)63518668. Item No. 42578100802, Lot No. 63518669, UDI (01)00880304809338(10)63518669.
Why it was recalled
Finishing guide does not adequately account for shape differences present in Size 8 of Persona Partial Knee System, potentially resulting in additional surgery time or sensation of tightness during knee flexion.
Root cause (FDA determination)
Device Design
Action the firm took
Customers were notified via FedEx mail and email on approximately 07/05/2017. Instructions included to notify appropriate personnel, complete and return the Acknowledgement Form, return affected product, and provide contact information of additional hospitals or surgeons that used the affected product.
Recalling firm
- Firm
- Zimmer Biomet, Inc.
- Address
- 56 E Bell Dr, Warsaw, Indiana 46582-6989
Distribution
- Distribution pattern
- Distributed domestically to AZ, CA, CO, ID, IL, IN, MA, MD, MI, NJ, NM, PA, SC, TX, WA, WI. Distributed internationally to Belgium, France, Germany, Italy, Japan, Netherlands, Spain, Sweden, United Kingdom.
Timeline
- Recall initiated
- 2017-07-05
- Terminated
- 2019-04-02
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #160230. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.