Zimmer Biomet, Inc.: Medical Device Recall in 2018 - (Recall #: Z-1805-2018)

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 Stemmed Tibial Provisional Size H Left, Item Number 42532108301 For use during orthopaedic surgery for implantation of a prosthesis.

Product Classification:

Class II

Date Initiated: August 7, 2017

Date Posted: May 23, 2018

Recall Number: Z-1805-2018

Event ID: 79991

Reason for Recall:

There is a potential for intermittent cracks in the raw material batch used to produce the affected products. The cleanliness of the affected products could be compromised if cracks penetrate the surface of the instrument as a result of the raw material issue.

Status: Terminated

Product Quantity: 842 products in total

Code Information:

Lot 63535352, UDI (01)00889024246935(10)63607357; Lot 63535352, UDI (01)00889024246935(10)63535352

Distribution Pattern:

Worldwide Distribution: US (nationwide) to states of: AK, AL, AR, AZ, CA, CO, FL, GA, IA, IL, IN, KS, KY, MA, MD, MI, MN, MO, MT, NC, NJ, NY, OH, OR, PA, SC, TX, UT, VA, WA, WI, and Puerto Rico; and to countries of: Australia, Canada, Hong Kong, India, Japan, Korea, Malaysia, Netherlands, and Singapore.

Voluntary or Mandated:

Voluntary: Firm initiated