CLASS II Device recall · Reported 14 Aug 2019 · FDA Enforcement Report
Certain(r) Bellatek(r) Titanium Abutment recalled by Biomet 3i
Biomet 3i is recalling Certain(r) Bellatek(r) Titanium Abutment, distributed nationwide in the US. The recall was initiated on 26 Feb 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2144-2019
- FDA event ID
- 82263
- Recalling firm
- Biomet 3i, Palm Beach Gardens, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 26 Feb 2019
- FDA classified
- 2 Aug 2019
- Reported
- 14 Aug 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Other Reasons
- Device type
- Dental Devices
Timeline
| 26 Feb 2019 | Recall initiated by company | |
| 2 Aug 2019 | Classified by FDA | +157 days |
| 14 Aug 2019 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
During manufacturing, the screw stop ledge was not made to specification and location within the abutment, resulting in the screw head seating deeper in the abutment with no positive stop.
Product as listed by the FDA
CERTAIN(R) BELLATEK(R) TITANIUM ABUTMENT 3.4MM, Item Number ILDAT3 - Product Usage:BIOMET3i Restorative products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible
Where it was distributed
Nationwide and Puerto Rico, Canada, and Australia
Questions about this recall
Is Certain(r) Bellatek(r) Titanium Abutment recalled?
Yes. Biomet 3i recalled Certain(r) Bellatek(r) Titanium Abutment on 26 Feb 2019. The recall is Class II and its status is Terminated. Recall number Z-2144-2019.
Why was it recalled?
During manufacturing, the screw stop ledge was not made to specification and location within the abutment, resulting in the screw head seating deeper in the abutment with no positive stop.
Which lots are affected?
Lot Numbers/UDI: 8442579-2/(01)00844868031390(10)8442579-2 8442701-1/(01)00844868031390(10)8442701-1 8442701-3/(01)00844868031390(10)8442701-3 8442692-1/(01)00844868031390(10)8442692-1 8442681-1/(01)00844868031390(10)8442681-1 8442663-1/(01)00844868031390(10)8442663-1 8442688-1/(01)00844868031390(10)8442688-1 8442837-1/(01)00844868031390(10)8442837-1 8442837-2/(01)00844868031390(10)8442837-2 8442657-1/(01)00844868031390(10)8442657-1 8442657-2/(01)00844868031390(10)8442657-2 8442674-1/(01)00844868031390(10)8442674-1 6867796-1/(01)00844868031390(10)6867796-1 8442805-1/(01)00844868031390(10)8442805-1 8442895-1/(01)00844868031390(10)8442895-1 8442811-1/(01)00844868031390(10)8442811-1 8442841-1/(01)00844868031390(10)8442841-1 8442720-1/(01)00844868031390(10)8442720-1 8442799-2/(01)00844868031390(10)8442799-2 8442765-1/(01)00844868031390(10)8442765-1 8442914-2/(01)00844868031390(10)8442914-2 8442944-1/(01)00844868031390(10)8442944-1 8443029-2/(01)00844868031390(10)8443029-2 8442940-2/(01)00844868031390(10)8442940-2 8443035-1/(01)00844868031390(10)8443035-1 8442948-1/(01)00844868031390(10)8442948-1 8443044-1/(01)00844868031390(10)8443044-1 8442965-1/(01)00844868031390(10)8442965-1 8442954-1/(01)00844868031390(10)8442954-1 8442949-1/(01)00844868031390(10)8442949-1 8442970-1/(01)00844868031390(10)8442970-1 8442930-1/(01)00844868031390(10)8442930-1 8443242-1/(01)00844868031390(10)8443242-1 8443098-1/(01)00844868031390(10)8443098-1 8442937-1/(01)00844868031390(10)8442937-1 8443046-1/(01)00844868031390(10)8443046-1 8442927-1/(01)00844868031390(10)8442927-1 8442936-1/(01)00844868031390(10)8442936-1 8442935-1/(01)00844868031390(10)8442935-1 8442997-1/(01)00844868031390(10)8442997-1 8443187-1/(01)00844868031390(10)8443187-1 8443018-1/(01)00844868031390(10)8443018-1 8443010-1/(01)00844868031390(10)8443010-1 8443230-1/(01)00844868031390(10)8443230-1 8443102-1/(01)00844868031390(10)8443102-1 8443231-1/(01)00844868031390(10)8443231-1 8443193-1/(01)00844868031390(10)8443193-1 8443248-1/(01)00844868031390(10)8443248-1 8443213-1/(01)00844868031390(10)8443213-1
Where was it sold?
Nationwide and Puerto Rico, Canada, and Australia
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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