XTANT Medical Holdings, Inc: nanOss 3D Advanced Bone Graft Substitute nanOss 3D Plus Advanced Bone Graft Substitute 90-300-251008: nanOss 3D Advanced Bone Graft Substitute, 25x100x8mm, 20cc 90-300-255

Hazard

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

Details from the source

Reason for recall: Products were incorrectly labeled with a 5-year shelf life. The approved and validated shelf life is four years. Distribution: US Nationwide distribution in the states and territories of CA, CT, DC, KS, MD, NC, NY, TX, and WI. Quantity: 225 Lot/code info: Part #: 90-300-251008 UDI-DI 00849777012478 Lot #(s): 385486-RP25-0080 387070-RP25-0081 415971-RP25-0077 436563-RP25-0082 436564-RP25-0079 436565-RP25-0076 444927-RP25-0078 Part #: 90-300-25508 UDI-DI 00849777012492 Lot #(s): 387071-RP25-0083 418098-RP25-0084 436199-RP25-0085 Part #: 90-300-251004 UDI-DI 00849777012461 Lot #(s): 401347-RP25-0070 415871-RP25-0073 415872-RP25-0074 416678-RP25-0072 416679-RP25-0071 418509-RP25-0075 Part #: 90-400-25508 UDI-DI 00849777012539 Lot #(s): 445442-RP25-0128

UPC codes

00849777012478, 00849777012492, 00849777012461, 00849777012539

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.