Class 2 Device Recall Bioactive Bone Graft Putty

• Date Initiated by Firm: February 13, 2019
• Create Date: April 15, 2019
• Recall Status: Terminated on November 02, 2020
• Recall Number: Z-1148-2019
• Recall Event ID: 82294
• 510(K)Number: K132071
• Product Classification: Filler, bone void, calcium compound - Product Code MQV
• 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.
• Code Information: 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
• Recalling Firm/ Manufacturer: Bioventus, LLC; 1900 Charles Bryan Rd Ste 275; Cordova TN 38016-5285
• For Additional Information Contact: Thomas Hill; 919-474-6719
• Manufacturer 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.
• FDA Determined 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 in Commerce: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = MQV and Original Applicant = BIOSTRUCTURES, LLC