The Recall Desk
HighFDA (Devices)·Z-1047-2019·Announced 2019-04-03

Avitus Bone Harvester Recalled for Potential Sterility Compromise

Avitus Orthopaedics is recalling 207 Bone Harvesters due to a breach in the sterile barrier pouch that may compromise device sterility.

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 (sterile medical device) where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Avitus Orthopaedics, Inc. is recalling 207 units of the Avitus Bone Harvester with Filter Insert (5mm), Catalog Number BH-210. The device is intended to harvest cancellous bone and bone marrow. The recall is due to a breach in the sterile barrier pouch, which may compromise the sterility of the device.

The affected lots are Z2458287A (expiration date 2018-06-01) and Z2458379A (expiration date 2018-10-01). The products were distributed nationwide in the United States to Arizona, California, Connecticut, Florida, Maryland, Michigan, New Mexico, Ohio, and Pennsylvania, as well as internationally to Brazil.

Healthcare providers and patients should stop using the recalled devices and contact Avitus Orthopaedics, Inc. for further instructions on return or replacement.

The recalled product

Product
Avitus¿ Bone Harvester w/ Filter Insert - 5mm intended to harvest cancellous bone and bone marrow Catalog Number: BH-210 The Avitus¿ Bone Harvester is intended to harvest cancellous bone and bone marrow
Manufacturer
Avitus Orthopaedics, Inc.
Category
Medical Device — Orthopedic Instrument
Hazard
Affected units
207

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 Number/Exp. Date Z2458287A 2018-06-01
  • Z2458379A 2018-10-01

Distribution

Distributed nationwide across the United States.

The notice also names 9 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Avitus Orthopaedics, 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 →

Related recalls

Same manufacturer · Avitus Orthopaedics, Inc.

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Same hazard · sterility compromise

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