OPTEFORM® Allograft Disc, 30mm x 3mm, 2cc 002530Recalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier.

12 other recalls cover devices cleared under the same FDA submission (K043421); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Apr 26, 2019Class IITerminated

   The Opteform Disc-30mm, Opteform Disc-45mm, and Opteform Disc-90mm were potentially exposed to higher temperatures than those documented in the IFU due to a failure of the cold storage equipment.

   Z-1688-2019 · Root cause: Environmental control · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K043421. One submission often covers many models, so check the product and lot details in each record.

• Z-1690-2019 · Apr 26, 2019 · Terminated
  Opteform Allograft Disc, 90mm x 5mm, 22cc, Catalog Number 600-03-90
• Z-1689-2019 · Apr 26, 2019 · Terminated
  Opteform Allograft Disc, 45mm x 5mm, 8cc, Catalog Number 600-03-45
• Z-1441-2017 · Jan 23, 2017 · Terminated
  RTI Biologics BioSet IC RT Paste 2 cc Filler, bone void, calcium compound. Use in dental, spine and orthopedic applications
• Z-0939-2014 · Dec 6, 2013 · Terminated
  ***REF 606-01-05***OPTEFORM Allograft Paste 5 cc, bone void filler of bony defects in dental and orthopedic applications.***STERILE Using Radiation. ***Rx Only***Distributor: EXAC
• Z-0495-06 · Oct 14, 2005 · Terminated
  Product is RTI Allograft Paste of varying sizes. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***'
• Z-0489-06 · Oct 14, 2005 · Terminated
  Osteofil RT, ICM Allograft Paste of varying sizes. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY**
• Z-0501-06 · Oct 14, 2005 · Terminated
  Product is 2.0 cc Opteform RT. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''.
• Z-0482-06 · Oct 14, 2005 · Terminated
  Product is OPTEFORM Allografts of varying sizes. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***'
• Z-0483-06 · Oct 14, 2005 · Terminated
  Product is OPTEFORM Allograft Paste of varying sizes. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ON
• Z-0488-06 · Oct 14, 2005 · Terminated
  Osteofil ICM Moldable Strip of varying sizes. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''.
• Z-0485-06 · Oct 14, 2005 · Terminated
  Osteofil + RT Allograft Paste in varying sizes. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''
• Z-0484-06 · Oct 14, 2005 · Terminated
  OPTEFORM RT Moldable Allograft of varying sizes. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***