Recall Z-3209-2017— Zimmer Dental Inc
Class II · Terminated
Class II FDA medical device recall by Zimmer Dental Inc, initiated 2017-07-10, terminated 2019-08-05. FDA's recall record names no specific 510(k) clearance for this event. Product: WAXING COPING, CONT 3.5 MM,ANG, REF ZOCWAX3A; WAXING COPING, CONT 3.5 MM, REF ZOCWAX3S; WAXING COPING, CONT 4.5MM, ANG, REF ZOCWAX4A; WAXING COPING, CONT 4.5MM, REF ZOCWAX4S; WAXING COPING, CONT, 5.5MM,ANG, REF ZOCWAX5A; WAXING COPING, CONT, 5.5MM, REF ZOCWAX5S; WAXING COPING, CONT, 6.5MM,ANG, REF ZOCWAX6A; WAXING COPING, CONT, 6.5MM, REF ZOCWAX6S. Reason: Zimmer Biomet is conducting a medical device field correction for various dental products due to several parts being shipped to the customer with only standard IFUs. All the products were missing supplemental IFUs..
- Recalling firm
- Zimmer Dental Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-07-10
- Terminated
- 2019-08-05
- Firm location
- Carlsbad, CA, United States
Product description
WAXING COPING, CONT 3.5 MM,ANG, REF ZOCWAX3A; WAXING COPING, CONT 3.5 MM, REF ZOCWAX3S; WAXING COPING, CONT 4.5MM, ANG, REF ZOCWAX4A; WAXING COPING, CONT 4.5MM, REF ZOCWAX4S; WAXING COPING, CONT, 5.5MM,ANG, REF ZOCWAX5A; WAXING COPING, CONT, 5.5MM, REF ZOCWAX5S; WAXING COPING, CONT, 6.5MM,ANG, REF ZOCWAX6A; WAXING COPING, CONT, 6.5MM, REF ZOCWAX6S
Reason for recall
Zimmer Biomet is conducting a medical device field correction for various dental products due to several parts being shipped to the customer with only standard IFUs. All the products were missing supplemental IFUs.
Data sourced from openFDA. This site is unofficial and independent of the FDA.