The Recall Desk
ModerateFDA (Devices)·Z-2595-2017·Announced 2017-06-21

Zimmer Biomet Recalls R-F IM Nails Due to Packaging Design Failures

Zimmer Biomet is recalling 3,856 sterile-packaged R-F IM Nails because packaging design verification tests failed. The action covers units distributed domestically and internationally.

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 involves packaging design verification failures without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Zimmer Biomet, Inc. is initiating a field action for 3,856 units of sterile-packaged R-F IM Nails. The recall involves various sizes of the R-F IM Nail, including 10mm, 11mm, 12mm, 13mm, and 14mm diameters with lengths ranging from 34cm to 48cm. The specific reason for the field action is packaging design verification test failures.

The affected devices were distributed to domestic locations including Puerto Rico and numerous US states, as well as to foreign locations in countries such as Canada, Australia, China, Germany, and the United Kingdom. The recall includes specific lot numbers and item numbers associated with the sterile packaging configuration.

Consumers and healthcare providers should contact Zimmer Biomet for further instructions regarding the return or replacement of these devices. The source text does not report any illnesses or injuries associated with this recall.

The recalled product

Product
R-F IM NAIL 10MMDX48CM LG, 11MMDX42CM, 11MMDX44CM, 11MMDX46CM LG, 11MMDX48CM LG, 12MMDX46CM LG, 12MMDX48CM LG, 13MMDX40CM, 13MMDX42CM, 13MMDX44CM, 13MMDX46CM LG, 13MMDX48CM LG, 14MMDX34CM, 14MMDX36CM, 14MMDX38CM, 14MMDX40CM, 14MMDX42CM, 14MMDX44CM, 14MMDX46CM LG, 14MMDX48CM LG
Manufacturer
Zimmer Biomet, Inc.
Category
Medical Device — Orthopedic Implants
Hazard
Affected units
3,856

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 (2)

  • 510K: K965098
  • K142281

Distribution

Distributed in 50 states:

Part of a larger recall action

This product is one of 8 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 8 products in this recall →

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