CLASS II Device recall · Reported 28 Dec 2016 · FDA Enforcement Report
Low Profile Abutment Non-hexed Preformance Temporary recalled
Biomet 3i is recalling Biomet 3i Low Profile Abutment Non-hexed Preformance Temporary Cylinder An endosseous. The recall was initiated on 14 Sep 2016 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-0858-2017
- FDA event ID
- 75761
- Recalling firm
- Biomet 3i, Palm Beach Gardens, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 14 Sep 2016
- FDA classified
- 20 Dec 2016
- Reported
- 28 Dec 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Packaging Defects
- Device type
- Dental Devices
Timeline
| 14 Sep 2016 | Recall initiated by company | |
| 20 Dec 2016 | Classified by FDA | +97 days |
| 28 Dec 2016 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
A limited number of product pouches may not have been sealed during packaging.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
BIOMET 3i LOW PROFILE ABUTMENT NON-HEXED PREFORMANCE TEMPORARY CYLINDER An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
Where it was distributed
Worldwide Distribution to Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Ireland, Italy, Lithuania, Portugal and Sweden
Questions about this recall
Is Low Profile Abutment Non-hexed Preformance Temporary Cylinder An endosseous dental recalled?
Yes. Biomet 3i recalled Low Profile Abutment Non-hexed Preformance Temporary Cylinder An endosseous dental on 14 Sep 2016. The recall is Class II and its status is Terminated. Recall number Z-0858-2017.
Why was it recalled?
A limited number of product pouches may not have been sealed during packaging.
Which lots are affected?
Part #LPCPTC2 Lot #'s 2016011174, 2016011175 and 2016011178
Where was it sold?
Worldwide Distribution to Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Ireland, Italy, Lithuania, Portugal and Sweden
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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