Persona recall
Persona Partial Knee spacer block instruments; (1) 8mm block, Model Number: 42-5399-035-08; (2) 9mm block, Model Number:42-5399-035-09; (3) 10mm…
Why was Persona recalled?
Certain partial knee implant spacer blocks do not fit in the alignment tower instrument or handle.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
(1) 8mm block, Model Number: 42-5399-035-08, Lots: 63767442 and 63807190; (2) 9mm block, Model Number:42-5399-035-09, Lot: 63769804; (3) 10mm block, Model Number: 42-5399-035-10, Lot: 63769805; (4) 12mm block, Model Number: 42-5399-035-12, Lot: 63769806; (5) 14mm block, Model Number: 42-5399-035-14, Lots: 63767443 and 63813674
- Product
- Persona Partial Knee spacer block instruments; (1) 8mm block, Model Number: 42-5399-035-08; (2) 9mm block, Model Number:42-5399-035-09; (3) 10mm…
- Recalling firm
- Zimmer Biomet, Inc.
- Quantity
- 1023
- Distribution
- USA (nationwide) Distribution to the states of : AL, AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI., and Internationally to Japan and Netherlands.
- Recall date
- April 4, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)