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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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.
- 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
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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