Recall Z-1148-2019— Bioventus, LLC
Class II · Terminated
Class II FDA medical device recall by Bioventus, LLC, initiated 2019-02-13, terminated 2020-11-02. It names one FDA 510(k) clearance: K132071. 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.. Reason: The firm became aware of the potential for the products' sterile pouch to be punctured during transit. The packaging failure may introduce a non-sterile device that may lead to patient infection..
- Recalling firm
- Bioventus, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-02-13
- Terminated
- 2020-11-02
- Firm location
- Cordova, TN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
The firm became aware of the potential for the products' sterile pouch to be punctured during transit. The packaging failure may introduce a non-sterile device that may lead to patient infection.
Data sourced from openFDA. This site is unofficial and independent of the FDA.