Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 82294

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
February 13, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Bioventus, LLC

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-1148-2019
Recall number
Z-1148-2019
Initiated
February 13, 2019
Classification
Class II
Status
Terminated
Recalling firm
Bioventus, LLC
Quantity
10,793

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
packaging failure
Sterility assurance reason.sterility_assurance · v1.0.0
sterile pouch to be punctured during transit. The packaging failure

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

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.

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

Distribution pattern

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.