Bioventus Recalls Bioactive Bone Graft Putty Due to Sterility Risk
Bioventus is recalling 10,793 units of Bioactive Bone Graft Putty because sterile pouches may puncture during transit, potentially introducing non-sterile devices and causing patient infection.
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 patient infection due to a potential loss of sterility in a medical device. Per the rubric, this is classified as High (3) because it is a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Bioventus, LLC is recalling 10,793 units of BIOVENTUS Bioactive Bone Graft Putty 15g. The product is a sterile filler device intended for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. It is sold under the brand names SIGNAFUSE, OSTEOFUSE, and MEDLINE UNITE.
The recall was initiated because the firm became aware of the potential for the products' sterile pouch to be punctured during transit. This packaging failure may introduce a non-sterile device, which may lead to patient infection.
The affected units were distributed in AK, AZ, CA, CO, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MO, NC, NE, NJ, NV, OH, OR, TN, TX, UT, WA, and WY. Specific catalog numbers and lot numbers are listed in the structured product information. Healthcare providers and patients should check their inventory and contact Bioventus for further instructions.
The recalled product
- Product
- BIOVENTUS Bioactive Bone Graft Putty 15g Rx only/sterile. Filler device intended for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. Sold under the brand names of: SIGNAFUSE, OSTEOFUSE and MEDLINE UNITE.
- Manufacturer
- Bioventus, LLC
- Category
- Medical Device — Bone Graft
- Affected units
- 10,793
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 (20)
- Catalog #s SGF-150
- OF003
- and MSBG150 SGF 150 LOT NUMBERS N737 00104
- N737 00105
- N837 00146
- N837 00147
- N837 00148
- N937 00196
- N937 00197
- N937 00198
- N937 00199
- P637 00065
- P637 00067
- P637 00068
- P737 00113
- P737 00114
- P737 00115
- P837 00149
- P837 00152
- P837 00153
Distribution
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