Zimmer Biomet, Inc.: Medical Device Recall in 2018 - (Recall #: Z-1238-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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 block, Model Number: 42-5399-035-10; (4) 12mm block, Model Number: 42-5399-035-12; (5) 14mm block, Model Number: 42-5399-035-14 A spacer block is used to ensure the tibial resection Is sufficient and to verify limb alignment. After verification the distal femoral resecUon Is complete using the distal femoral cut slot in the spacer block. The spacer block determines how much distal femoral bone is resected.

Product Classification:

Class II

Date Initiated: November 29, 2017

Date Posted: April 4, 2018

Recall Number: Z-1238-2018

Event ID: 79383

Reason for Recall:

Certain partial knee implant spacer blocks do not fit in the alignment tower instrument or handle.

Status: Terminated

Product Quantity: 1023

Code Information:

(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

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated