Recall Z-1233-2014— Biomet 3i, LLC
Class III · Terminated
Class III FDA medical device recall by Biomet 3i, LLC, initiated 2013-10-03, terminated 2014-12-11. It names one FDA 510(k) clearance: K980679. Product: ENDOBON XENOGRAFT GRANULES 0.5 ML (Bovine bone substitute) Endobon is a bone substitute of bovine origin formed from ceramised bone for implantation or transplantation when bone is lost due to trauma or requested during reconstructive surgery.. Reason: Individual pieces of a batch of Biomet's Endobon Xenograft Granules 0.5 ML (Bovine Bone substitute) may have an incorrect label with the wrong batch number..
- Recalling firm
- Biomet 3i, LLC
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2013-10-03
- Terminated
- 2014-12-11
- Firm location
- Palm Beach Gardens, FL, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
ENDOBON XENOGRAFT GRANULES 0.5 ML (Bovine bone substitute) Endobon is a bone substitute of bovine origin formed from ceramised bone for implantation or transplantation when bone is lost due to trauma or requested during reconstructive surgery.
Reason for recall
Individual pieces of a batch of Biomet's Endobon Xenograft Granules 0.5 ML (Bovine Bone substitute) may have an incorrect label with the wrong batch number.
Data sourced from openFDA. This site is unofficial and independent of the FDA.