The Recall Desk
HighFDA (Devices)·Z-0594-2020·Announced 2019-12-11

Zimmer Biomet Recalls 13MM Intramedullary Bone Saw Cam Assemblies

Zimmer Biomet is recalling 26 units of 13MM Intramedullary Bone Saw Cam Assemblies due to possible commingling with 14MM units.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (surgical instrument) where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Zimmer Biomet, Inc. is recalling 26 units of the Biomet Orthopedics Intramedullary Bone Saw Cam Assembly 13MM (Item Number: 475660). The recall is due to a possible commingling issue where an Intramedullary Bone Saw Cam Assembly was labeled and etched as a 14 MM unit but measured as a 13 MM cam.

The affected units are distributed to US states of CA, FL, IN, MN, MO, NY, and UT, as well as Australia and New Zealand. The specific lot numbers involved are 025800, 025810, and 081640.

Healthcare facilities and consumers should stop using the affected products and contact Zimmer Biomet for further instructions.

The recalled product

Product
Biomet Orthopedics Intramedullary Bone Saw Cam Assembly 13MM-Orthopedic manual surgical instrument Item Number: 475660
Affected units
26

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)

  • Lot Numbers: 025800
  • 025810

Distribution

Distributed in 7 states:

Part of a larger recall action

This product is one of 2 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 2 products in this recall →