The Recall Desk
ModerateFDA (Devices)·Z-0305-2020·Announced 2019-11-13

Zimmer Biomet Recalls ZPLP Fibular Plates Due to Packaging Adhesion

Zimmer Biomet is recalling ZPLP Fibular Plates because non-highly polished implants may adhere to the LDPE bag packaging.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a packaging defect (adhesion) rather than a direct structural failure or reported injury, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Zimmer Biomet, Inc. is recalling ZPLP Fibular Plates, identified by specific item numbers, due to a packaging issue. The recall involves 5,459,583 total devices that were distributed nationwide. The affected products are all units manufactured prior to January 2014.

The reason for the recall is that non-highly polished implants may adhere to the LDPE bag, which was the previous packaging configuration. This adhesion could potentially complicate the handling or inspection of the devices prior to use.

Healthcare providers and facilities that have received these devices should stop using them and contact Zimmer Biomet for further instructions on how to return or dispose of the affected units.

The recalled product

Product
ZPLP Fibular Plate, Item Nos. 00234701504 00234701506 00234701508 00234701510 00234701512 00234701516 00234701604 00234701606 00234701608 00234701610 00234701612 00234701614 00234701616 00234701702 00234701704 00234701706 00234701708 00234701710 00234701712 002
Affected units
5,459,583

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All product manufactured prior to January 2014.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 41 recalled by Zimmer Biomet, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 41 products in this recall →