RecallRadar

FDA Device recall Z-0734-2019

Maximum Variable Pitch Compression Tray Base, Reference Number 231201002 Product Usage: Intended to carry implants and instruments during r…

On 2019-01-23 the FDA classified a Class II recall of Maximum Variable Pitch Compression Tray Base, Reference Number 231201002 Product Usage: Intended to carry implants and instruments during r… by Zimmer Biomet, citing there is a potential for silicone shedding during cleaning and sterilization.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0734-2019
ClassificationClass II
Statusterminated
Initiated2018-11-28
Published2019-01-23
Last updated2026-09-13 11:55 UTC
CompanyZimmer Biomet
DistributionUS

Product

Maximum Variable Pitch Compression Tray Base, Reference Number 231201002 Product Usage: Intended to carry implants and instruments during regular inventory distribution and handling and sterilization in the hospitals

Reason

There is a potential for silicone shedding during cleaning and sterilization.

Identifiers

code_infoLot Numbers 453392 453918 453919 469917 475577 481064 481065 486820 498695 506818 512868

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0734-2019%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.