ModerateClass IITerminated

FDA Devices recall · Reported September 5, 2012

Low Profile Abutment, Non-Hexed Castable Cylinder Model LPCCC1. Product is labeled in part: "REF LPCCC1Low profile Abutment Hexed Castable CylinderCylinder; Cylindre; Zylinder; Cilindro; Cilindro; CilindroRX onlyNON STERILECaution: Law prohibits dispensing without prescriptionConsult instructions for use Castable cylinders are intended to be used to produce a definitive casting for dental restoration onto which porcelain can then be cast.

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on September 5, 2012. Severity: Moderate. Recall number: Z-2271-2012.

Q: Where was the recalled product distributed?

Distribution: Worldwide Distribution-Distributed in the USA and the countries to Spain, France, Germany, Switzerland, and Australia..

Q: How do I check if my product is affected by a recall?

Check the product description and recall number (Z-2271-2012) 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.

Q: 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.

Biomet 3i conducted a recall on the device Low Profile Abutment, Non-Hexed Castable Cylinder due to some packages labeled LPCCC1, Hexed Castable Cylinder possibly containing LPCCC…

Recall #: Z-2271-2012
Affected scope: 611 units
Initiated: May 31, 2012

Compiled from official public sources by the editorial team. · Updated July 2026

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Biomet 3i, LLC recalled Low Profile Abutment, Non-Hexed Castable Cylinder Model LPCCC1. Product is labeled in pa… - a moderate-severity action.

Low Profile Abutment, Non-Hexed Castable Cylinder Model LPCCC1. Product is labeled in pa… was recalled by Biomet 3i, LLC in September 5, 2012. Reason: Biomet 3i conducted a recall on the device Low Profile Abutment, Non-Hexed Castable Cylinder due to some pack…. Check the official notice for the remedy. Verify recall #Z-2271-2012 with the FDA Devices before acting.

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The recall

Biomet 3i, LLC issued this moderate-severity FDA Devices recall-Biomet 3i conducted a recall on the device Low Profile Abutment, Non-Hexed Castable Cylinder due to some pack….

Moderate
severity level: 611 units
affected scope: Class II
classification: September 5, 2012
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-2271-2012 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This FDA Devices action (record #Z-2271-2012) was formally reported on September 5, 2012, with the manufacturer initiating the action on May 31, 2012. 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 611 units.

The documented reason for this recall is: Biomet 3i conducted a recall on the device Low Profile Abutment, Non-Hexed Castable Cylinder due to some packages labeled LPCCC1, Hexed Castable Cylinder possibly containing LPCCC2, Non-Hexed Castable Cylinders. Distribution data in the federal record shows the product reached: Worldwide Distribution-Distributed in the USA and the countries to Spain, France, Germany, Switzerland, and Australia.. 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.

Where this recall sits in the database

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.

Severity

Moderate

Affected scope

611 units

Related Recalls

3 from same agency

Product description

Low Profile Abutment, Non-Hexed Castable Cylinder Model LPCCC1. Product is labeled in part: "***REF LPCCC1***Low profile Abutment Hexed Castable Cylinder***Cylinder; Cylindre; Zylinder; Cilindro; Cilindro; Cilindro***RX only***NON STERILE***Caution: Law prohibits dispensing without prescription***Consult instructions for use*** Castable cylinders are intended to be used to produce a definitive casting for dental restoration onto which porcelain can then be cast.

Reason for recall

Biomet 3i conducted a recall on the device Low Profile Abutment, Non-Hexed Castable Cylinder due to some packages labeled LPCCC1, Hexed Castable Cylinder possibly containing LPCCC2, Non-Hexed Castable Cylinders.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Terminated
Recall number	Z-2271-2012
Date reported	September 5, 2012
Date initiated	May 31, 2012
Recalling firm	Biomet 3i, LLC
Firm location	Palm Beach Gardens, FL
Affected scope	611 units
Distribution	Worldwide Distribution-Distributed in the USA and the countries to Spain, France, Germany, Switzerland, and Australia.

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

611 units units affected - limited or regional distribution scale.

Regional (<10K units) ✓ This recall

Multi-state (10K – 100K units) -

Large-scale (100K – 1M units) -

Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (Z-2271-2012) 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? ▼

Why was this product recalled? ▼

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on September 5, 2012. Severity: Moderate. Recall number: Z-2271-2012.

Where was the recalled product distributed? ▼

Distribution: Worldwide Distribution-Distributed in the USA and the countries to Spain, France, Germany, Switzerland, and Australia..

How do I check if my product is affected by a recall? ▼

Check the product description and recall number (Z-2271-2012) 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 September 5, 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.