The Recall Desk
ModerateFDA (Devices)·Z-0309-2020·Announced 2019-11-13

Zimmer Biomet Recalls Tibia Lock Plates Due to Packaging Adhesion

Zimmer Biomet is recalling Prox Lat Tib Lock Plates and Dist Med Tib Lock 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, but the specific hazard is a packaging adhesion issue without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Zimmer Biomet, Inc. is recalling Prox Lat Tib Lock Plates and Dist Med Tib Lock Plates. The recall involves 5,459,583 total devices distributed nationwide. The affected products include specific item numbers manufactured prior to January 2014.

The recall was initiated because non-highly polished implants may adhere to the LDPE bag, which was the previous packaging configuration. This issue could potentially complicate the handling or removal of the implant from its packaging.

Healthcare providers and facilities that have received these devices should contact Zimmer Biomet for instructions on how to proceed. Consumers who have had these implants placed should consult their healthcare provider if they have concerns regarding the packaging or the device itself.

The recalled product

Product
Prox Lat Tib Lock Plate and Dist Med Tib Lock Plate Item Nos. 47235700306 47235700308 47235700310 47235700312 47235700314 47235700408 47235700410 47235700412 47235700414 47235700416 47235700504 47235700506 47235700508 47235700510 47235700512 47235700514 4723570
Manufacturer
Zimmer Biomet, Inc.
Category
Medical Device — Orthopedic Implants
Hazard
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 →

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