Filler, Bone Void, Calcium Compound

OsteoBallast, 45 x 17.5 mm (SeaSpine Brand), REF: 56800095.

Demineralized bone matrix (DBM) in resorbable mesh indicated for use with autograft as a bone graft extender in the posterolateral spine and pelvis, were filled with approx. 4.5 cc DBM (fill for 45 11 mm configuration) instead of approx. 7.5 cc DBM (fill for 45 17.5 mm configuration), which may lead to delayed fusion, incomplete fusion, pseudarthrosis, or lack of bone ingrowth.

BioCera Fibers, Bioresorbable Bone Void Filler, REF: ORB-0320C-KC, ORB-0310C-KC, ORB-0304C-KC, ORB-0302C-KC, ORB-0305D-KC

Resorbable bone void filler falls outside standard specifications.

ZENBONE, REF: ORB-0320C-Z, ORB-0310C-Z, ORB-0304C-Z

Resorbable bone void filler falls outside standard specifications.

nanOss 3D Advanced Bone Graft Substitute

Products were incorrectly labeled with a 5-year shelf life. The approved and validated shelf life is four years.

Tribio Implant 7.5mm x 40mm REF M80 SB008

Due to incorrect product label (Incorrect product name identified on outer packaging).

Bio 1 Granules for Filling 1 mm (2 cm), REF:P822692243, Material: BIOSORB (BTCP 95% minimum purity)

Vials of implant bone granules may contain less product then specified on labeling.

OsteoSurge 100 Demineralized Bone Matrix Putty with Accell Bone Matrix, OsteoSurge 100 Demineralized Bone Matrix, 10cc, REF 56300100.

Incorrect expiration date listed on the outer box, which does not align with the correct expiration date listed on the inner tray.

OsteoCove Putty, 1.25cc, REF 56920013 and Cove Putty, 1.25cc REF 02-9200-01.

Hydration issue resulting in the product being less cohesive and moldable than intended due to an issue with the polymer.

AFT (Allograft Filler Tube) Straight Tube (1/2 Filled), Product Code 227010 (bone void filler)

Filling process qualification did not demonstrate adequate process capability. Possible consequences include extended surgery time due to extrudability issues.

AFT (Allograft Filler Tube) Diverted Tube (3/4 Filled), Product Code 227005 (bone void filler)

Filling process qualification did not demonstrate adequate process capability. Possible consequences include extended surgery time due to extrudability issues.