The Recall Desk
ModerateFDA (Devices)·Z-0163-2019·Announced 2018-10-24

Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Issues

Zimmer Biomet is recalling 50 Affixus Hip Fracture Nails because complaints indicated the sterile packaging was already open when the products were opened in surgery.

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 compromised sterile packaging without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Zimmer Biomet, Inc. is recalling 50 units of the Affixus Hip Fracture Nail Right 130 13 mm x 360 mm (Item Number 814513360). The recall was initiated after complaints indicated that the sterile packaging for these medical devices was already open when the products were opened during surgery.

The affected products were distributed worldwide, including nationwide in the United States and in Chile and the Netherlands. The specific lot numbers involved in this recall are 436470, 616630, and 616640. The devices are intended for the fixation of fractures.

Healthcare providers and facilities should check their inventory for these specific item numbers and lot numbers. If the sterile packaging is found to be compromised or open, the devices should not be used. Patients who have already received these implants should contact their healthcare provider for guidance.

The recalled product

Product
Affixus Hip Fracture Nail Right 130 13 mm x 360 mm, Item Number 814513360 Product Usage: Intended for the fixation of fractures
Manufacturer
Zimmer Biomet, Inc.
Category
Medical Device — Orthopedic Implants
Hazard
Affected units
50

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)

  • Lot Numbers: 436470 616630 616640

Distribution

Distributed nationwide across the United States.

The notice also names 41 states specifically:

Part of a larger recall action

This product is one of 48 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 48 products in this recall →

Related recalls

Same manufacturer · Zimmer Biomet, Inc.

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Same hazard · sterile packaging compromise

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