Avitus Bone Harvester Recalled for Potential Sterility Compromise
Avitus Orthopaedics is recalling 508 Bone Harvester units because a breach in the sterile barrier pouch may compromise the device's 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 medical device where a breach in the sterile barrier may compromise sterility, representing a risk of harm (infection) where injury has not yet been reported, consistent with the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Avitus Orthopaedics, Inc. is recalling 508 units of the Avitus Bone Harvester with Filter Insert (8mm), Catalog Number BH-110. The device is intended to harvest cancellous bone and bone marrow. The recall was initiated because a breach in the sterile barrier pouch may compromise the sterility of the device.
The affected units 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. The specific lot numbers and expiration dates involved are Z2458218A (2018-05-01), Z2458253B (2018-05-01), Z2458379B (2018-10-01), and Z2458448B (2019-01-01).
Healthcare providers and facilities should check their inventory for these specific lot numbers and stop using the affected devices. Users should contact Avitus Orthopaedics, Inc. for instructions on returning the product or obtaining a replacement.
The recalled product
- Product
- Avitus¿ Bone Harvester w/ Filter Insert - 8mm intended to harvest cancellous bone and bone marrow Catalog Number: BH-110 The Avitus¿ Bone Harvester is intended to harvest cancellous bone and bone marrow
- Manufacturer
- Avitus Orthopaedics, Inc.
- Affected units
- 508
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 (4)
- Lot Number/Exp. Date Z2458218A 2018-05-01
- Z2458253B 2018-05-01
- Z2458379B 2018-10-01
- Z2458448B 2019-01-01
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.
See all →- HighAvitus Bone Harvester Recalled for Potential Sterility Compromise
FDA (Devices) · 2019-04-03
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