Recall Z-2074-2015— Nobel Biocare Usa Llc
Class II · Terminated
Class II FDA medical device recall by Nobel Biocare Usa Llc, initiated 2015-06-22, terminated 2015-09-18. FDA's recall record names no specific 510(k) clearance for this event. Product: Abutment Retrieval Instrument Zirconia CC RP/WP, Article No. 37882 and Abutment Retrieval Kit, Article No. 37508 (Article No. 37882 was assembled in this kit). Used to remove a zirconia abutment if the abutment is stuck in the implant connection due to a tight seat. Endosseous dental implant instrument.. Reason: One dimension of the affected instrument is incorrect. Therefore this instrument cannot be used to remove the metal adapter as intended..
- Recalling firm
- Nobel Biocare Usa Llc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-06-22
- Terminated
- 2015-09-18
- Firm location
- Yorba Linda, CA, United States
Product description
Abutment Retrieval Instrument Zirconia CC RP/WP, Article No. 37882 and Abutment Retrieval Kit, Article No. 37508 (Article No. 37882 was assembled in this kit). Used to remove a zirconia abutment if the abutment is stuck in the implant connection due to a tight seat. Endosseous dental implant instrument.
Reason for recall
One dimension of the affected instrument is incorrect. Therefore this instrument cannot be used to remove the metal adapter as intended.
Data sourced from openFDA. This site is unofficial and independent of the FDA.