Recalls / —
—#142019
Product
Persona EM Distal Rod, orthopedic manual surgical instrument for use with Persona Knee Prosthesis, item 42-5399-002-00, part of the Persona Tibial Resection System.
- FDA product code
- LXH — Orthopedic Manual Surgical Instrument
- Device class
- Class 1
- Medical specialty
- Orthopedic
- Affected lot / code info
- Distal Rod Item Number 42-5399-002-00 Lots: 62137112, 62156914, 62222599.
Why it was recalled
Complaints that the ratchet teeth of the tube are not latching onto the rod.
Root cause (FDA determination)
Under Investigation by firm
Action the firm took
Zimmer Biomet initiated a voluntary recall of the Persona EM Proximal Tube and Persona EM Distal Rod due to complaints that the ratchet teeth of the tube are not latching onto the rod via certified mail on 11/24/2015. The firm requests customers quarantine recalled devices, return the customer response forms, and assist in returning the devices to the Zimmer Biomet sales reps. Customers with questions may contact 1-800-348-2759 between 8:00 am and 8:00 pm EST.
Recalling firm
- Firm
- Zimmer, Inc.
- Address
- 1800 W Center St, Warsaw, Indiana 46580-2304
Distribution
- Distribution pattern
- Distributed in the states of AZ, CA, ID, IL, IN, KS, MA, MI, MN, MO, NC, NJ, NY, OH, PA, TN, TX, VA, and WA, and the country of Germany.
Timeline
- Recall initiated
- 2015-11-24
- Posted by FDA
- 2015-12-10
- Terminated
- 2017-03-24
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #142019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.