CLASS II Device recall · Reported 5 Apr 2017 · FDA Enforcement Report
Ltx Dental Implants recalled by Biomet 3i
Biomet 3i is recalling Biomet 3i Ltx Dental Implants. The recall was initiated on 8 Mar 2017 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-1701-2017
- FDA event ID
- 76809
- Recalling firm
- Biomet 3i, Palm Beach Gardens, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 8 Mar 2017
- FDA classified
- 29 Mar 2017
- Reported
- 5 Apr 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Dental Devices
Timeline
| 8 Mar 2017 | Recall initiated by company | |
| 29 Mar 2017 | Classified by FDA | +21 days |
| 5 Apr 2017 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
A single lot of product that potentially has a single part within the lot that does not match the product on the label due to a commingle at the firm supplier
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
BIOMET 3i LTX DENTAL IMPLANTS Model LTX610 (6x10mm) - Plastic tray within Tyvek tray within cardboard box; one (1) unit per box. Labeled Sterile"
Where it was distributed
Argentina
Questions about this recall
Is Ltx Dental Implants recalled?
Yes. Biomet 3i recalled Ltx Dental Implants on 8 Mar 2017. The recall is Class II and its status is Terminated. Recall number Z-1701-2017.
Why was it recalled?
A single lot of product that potentially has a single part within the lot that does not match the product on the label due to a commingle at the firm supplier
Which lots are affected?
LTX610, lot 1199571; UDI: (01)00844868009917(17)210916(10)1199571
Where was it sold?
Argentina
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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| Device | CLASS II | KL Owen Custom Orthodontic Solution recalled by Klowen Braces | Klowen Braces | Device Malfunction | Nationwide |
| Device | CLASS II | Straumann n!ce PMMA Full-arch Restoration recalled | Straumann USA | Other | 8 states |
| Device | CLASS II | Straumann n!ce Zr, HT, Full-arch Restoration recalled | Straumann USA | Other | 8 states |