Bioventus, LLC: 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.

Recall number

Z-1148-2019

Recalling firm

Bioventus, LLC

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.

Status

Terminated

Initiated

2019-02-13

Posted

not on file

Terminated

2020-11-02

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.

Root cause

Package design/selection

Action

On February 13, 2019, Bioventus sent URGENT: MEDICAL DEVICE RECALL Notification letters to their consignees requesting them to: Actions required by you: 1. Locate any unused products in affected part number and quarantine them immediately. 2. Carry out a physical count of all affected product in your possession and record this data on the Inventory Return Certification Form below. 3. Scan and email a copy of the completed Inventory Return Certification Form to: Notice2019-02@bioventusglobal.com a. Bioventus will email a Return Authorization number and Shipping Return Label after receiving the scanned Inventory Return Certification Form. 4. Return the recalled product along with the completed Inventory Return Certification Form using the provided Shipping Return Label. 5. Important: If you have distributed affected product further, please provide a copy of this Notification to these customers. 6. If you have additional questions, or to order replacement product in alternative sizes, please call Bioventus at (800) 637-4391.

Quantity

10,793

Distribution

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.

Lot, serial or model codes

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, Q737 00119, Q737 00120, Q837 00157, R637 00071, R637 00072, R637 00075, R737 00122, R837 00163, R837 00164, S437 00016, S737 00123, S837 00169, T637 00077, T637 00079, T737 00124, T737 00127, T837 00170, T837 00171, T837 00172, T837 00173, T837 00176, U637 00080, U637 00084, U737 00128, U737 00129, U837 00180, U837 00181, U837 00182, V637 00088, V637 00089, V737 00130, V737 00134, V837 00183, V837 00184, V837 00185, V837 00186, W637 00090, W737 00135, W737 00136, W737 00137, X637 00093, X637 00094, X637 00095, X737 00139, X837 00189, X837 00190, X837 00191, Y637 00098, Y737 00141, Z637 00063, Z737 00109, and Z737 00110.  OF003 LOT NUMBERS N837 00144, Q737 00121, Q837 00156, S837 00165, T437 00017, Y637 00100, and Z737 00107.   MSBG1500 LOT NUMBER  R837 00160

510(k) numbers

["K132071"]

PMA numbers

not on file

Product code

MQV

Firm FEI

3027669735

Firm city

Cordova

Firm state

TN

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

Copy