PlainRecalls
FDA Devices Moderate Class II Terminated

PROX LAT HUMERAL LOCK PLATE, Item Nos. 47235800104 47235800106 47235800108 47235800112 47235800116 47235800204 47235800206 47235800208 47235800212

Reported: November 13, 2019 Initiated: October 10, 2019 #Z-0316-2020

Product Description

PROX LAT HUMERAL LOCK PLATE, Item Nos. 47235800104 47235800106 47235800108 47235800112 47235800116 47235800204 47235800206 47235800208 47235800212

Reason for Recall

Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

Details

Recalling Firm
Zimmer Biomet, Inc.
Units Affected
5,459,583 total devices
Distribution
Distributed nationwide.
Location
Warsaw, IN

Frequently Asked Questions

What product was recalled?
PROX LAT HUMERAL LOCK PLATE, Item Nos. 47235800104 47235800106 47235800108 47235800112 47235800116 47235800204 47235800206 47235800208 47235800212. Recalled by Zimmer Biomet, Inc.. Units affected: 5,459,583 total devices.
Why was this product recalled?
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Which agency issued this recall?
This recall was issued by the FDA Devices on November 13, 2019. Severity: Moderate. Recall number: Z-0316-2020.