Recall Z-3210-2017— Zimmer Dental Inc
Class II · Terminated
Class II FDA medical device recall by Zimmer Dental Inc, initiated 2017-07-10, terminated 2019-08-05. It names 2 FDA 510(k) clearances: K071235, K052997. Product: IMPLANT,1-PC,ANG,3.0X10MM, REF ZOP30A10; IMPLANT, 1-PC, ANG, 3.0X11.5MM, REF ZOP30A11; IMPLANT, 1 -PC,ANG,3.0X13MM, REF ZOP30A13; IMPLANT 1-PC STR 3.0X10, REF ZOP30S10; IMPLANT, 1-PC,STR,3.0X11.5MM, REF ZOP30S11; IMPLANT,1 -PC,STR,3.0X13MM, REF ZOP30S13. 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
510(k) clearances named in this recall
2 on FDA's record- K071235 — ZIMMER ONE PIECE IMPLANT, 3.0MM ANGLED, MODELS ZOP30A10, ZOP30A11 AND ZOP30A13
- K052997 — ZIMMER DENTAL ONE-PIECE IMPLANT
K-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
IMPLANT,1-PC,ANG,3.0X10MM, REF ZOP30A10; IMPLANT, 1-PC, ANG, 3.0X11.5MM, REF ZOP30A11; IMPLANT, 1 -PC,ANG,3.0X13MM, REF ZOP30A13; IMPLANT 1-PC STR 3.0X10, REF ZOP30S10; IMPLANT, 1-PC,STR,3.0X11.5MM, REF ZOP30S11; IMPLANT,1 -PC,STR,3.0X13MM, REF ZOP30S13
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.