The Recall Desk
ModerateFDA (Devices)·Z-0327-2020·Announced 2019-11-13

Zimmer Biomet Recalls Cable-Ready Short and Long GTR Implants

Zimmer Biomet is recalling Cable-Ready Short and Long GTR implants because non-highly polished units may adhere to the LDPE bag.

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 source text describes a packaging/adhesion issue without reporting any injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Zimmer Biomet, Inc. is recalling Cable-Ready Short GTR and Cable-Ready Long GTR implants, Item Nos. 00223200201 and 00223200202. The recall involves 5,459,583 total devices that were distributed nationwide.

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 affect the handling or integrity of the device during the packaging process.

Healthcare providers and facilities that have received these specific implants should contact Zimmer Biomet for further instructions on how to manage the recalled products. Consumers are not directly affected as these are medical devices intended for professional use.

The recalled product

Product
CABLE-READY SHORT GTR and CABLE-READY LONG GTR, Item Nos. 00223200201 00223200202
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)

  • 77001932 77001933 77001878 62176030 62112090 62146839

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 →