Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported June 27, 2012
Implant, Dental, Endosseous, Acid Etched, ICE, Osseotite, Internal Connection. . Product is labeled in part: "***Certain 3.25, 13***REF IOSM313 LOT*** OSSEOTITE Certain Implant***3.25 x 13mm***CE 0086***Use by yyyy-mm***Sterile by radiation*** STERILE R***Do not re-sterile***RX only Caution: Law prohibits dispensing without prescription***do not use if package is damaged***do not reuse***consult instructions for use***Sterile unless package is opened or damaged.*** Product Usage: The
On November 3, 2011 Biomet 3i, Palm Beach Gardens, FL initiated a recall of their Osseotite Certain Implant, Model # IOSM313, Lot #2010111529. Dental implant lot may not have an …
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Biomet 3i, LLC recalled Implant, Dental, Endosseous, Acid Etched, ICE, Osseotite, Internal Connection. . Pr… - a moderate-severity action.
Implant, Dental, Endosseous, Acid Etched, ICE, Osseotite, Internal Connection. . Pr… was recalled by Biomet 3i, LLC in June 27, 2012. Reason: On November 3, 2011 Biomet 3i, Palm Beach Gardens, FL initiated a recall of their Osseotite Certain Implant, …. Check the official notice for the remedy. Verify recall #Z-1828-2012 with the FDA Devices before acting.
The recall
Biomet 3i, LLC issued this moderate-severity FDA Devices recall-On November 3, 2011 Biomet 3i, Palm Beach Gardens, FL initiated a recall of their Osseotite Certain Implant, ….
- Moderate
- severity level
- 219 units
- affected scope
- Class II
- classification
- June 27, 2012
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1828-2012 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1828-2012) was formally reported on June 27, 2012, with the manufacturer initiating the action on November 4, 2011. It is classified under Moderate severity (Class II), with a current status of Terminated. Biomet 3i, LLC is listed as the recalling firm, operating out of Palm Beach Gardens, FL. Federal records list the affected scope as 219 units in total.
The documented reason for this recall is: On November 3, 2011 Biomet 3i, Palm Beach Gardens, FL initiated a recall of their Osseotite Certain Implant, Model # IOSM313, Lot #2010111529. Dental implant lot may not have an internal thread. Distribution data in the federal record shows the product reached: Worldwide Distribution - US(nationwide) and the countries of: Brazil, Canada, Columbia, Italy, Lebanon, Spain, Switzerland, and UK.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
219 units in total
Related Recalls
6
3 from same agency
Product description
Implant, Dental, Endosseous, Acid Etched, ICE, Osseotite, Internal Connection. . Product is labeled in part: "***Certain 3.25, 13***REF IOSM313 LOT*** OSSEOTITE Certain Implant***3.25 x 13mm***CE 0086***Use by yyyy-mm***Sterile by radiation*** STERILE R***Do not re-sterile***RX only Caution: Law prohibits dispensing without prescription***do not use if package is damaged***do not reuse***consult instructions for use***Sterile unless package is opened or damaged.*** Product Usage: The BIOMET 3i Dental Implants are intended for surgical placement in the upper or lower jaw to provide a means of prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utilizing delayed or immediate loading or with a terminal or intermediary abutment for fixed or removable bridgework and to retain over dentures.
Reason for recall
On November 3, 2011 Biomet 3i, Palm Beach Gardens, FL initiated a recall of their Osseotite Certain Implant, Model # IOSM313, Lot #2010111529. Dental implant lot may not have an internal thread.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1828-2012 |
| Date reported | June 27, 2012 |
| Date initiated | November 4, 2011 |
| Recalling firm | Biomet 3i, LLC |
| Firm location | Palm Beach Gardens, FL |
| Affected scope | 219 units in total |
| Distribution | Worldwide Distribution - US(nationwide) and the countries of: Brazil, Canada, Columbia, Italy, Lebanon, Spain, Switzerland, and UK. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1828-2012) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Implant, Dental, Endosseous, Acid Etched, ICE, Osseotite, Internal Connection. . Product is labeled in part: "***Certain 3.25, 13***REF IOSM313 LOT*** OSSEOTITE Certain Implant***3.25 x 13mm***CE 0086***Use by yyyy-mm***Sterile by radiation*** STERILE R***Do not re-sterile***RX only Caution: Law prohibits dispensing without prescription***do not use if package is damaged***do not reuse***consult instructions for use***Sterile unless package is opened or damaged.*** Product Usage: The BIOMET 3i Dental Implants are intended for surgical placement in the upper or lower jaw to provide a means of prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utilizing delayed or immediate loading or with a terminal or intermediary abutment for fixed or removable bridgework and to retain over dentures.. Recalled by Biomet 3i, LLC. Units affected: 219 units in total.
Why was this product recalled? ▼
On November 3, 2011 Biomet 3i, Palm Beach Gardens, FL initiated a recall of their Osseotite Certain Implant, Model # IOSM313, Lot #2010111529. Dental implant lot may not have an internal thread.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 27, 2012. Severity: Moderate. Recall number: Z-1828-2012.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - US(nationwide) and the countries of: Brazil, Canada, Columbia, Italy, Lebanon, Spain, Switzerland, and UK..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1828-2012) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported June 27, 2012. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.