ModerateClass IITerminated

FDA Devices recall · Reported August 15, 2012

PopLok Punch labeled in part: "PKL-35M3.5mmQTY 1PopLok PunchConMed Linvatec Biomaterials, Ltd. Hermiankatu 6-8L 33720 Tampere, FINLANDRx OnlyConMed Linvatec 11311 Concept Blvd Largo, FL 33773-4908 USAMade in USA" Intended Use: Bone Punch.

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on August 15, 2012. Severity: Moderate. Recall number: Z-2151-2012.

Q: Where was the recalled product distributed?

Distribution: Worldwide Distribution -- US and Korea..

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

Check the product description and recall number (Z-2151-2012) 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.

ConMed Linvatec recalled one lot of their PopLok bone Punch 3.5MM because the metal shaft diameter is 4.5mm when it should have been 3.5mm.

Recall #: Z-2151-2012
Affected scope: 2
Initiated: July 6, 2012

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

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Linvatec Corp. dba ConMed Linvatec recalled PopLok Punch labeled in part: "PKL-35M***3.5mm***QTY 1***PopLok Punch***ConMed Linvatec … - a moderate-severity action.

PopLok Punch labeled in part: "PKL-35M***3.5mm***QTY 1***PopLok Punch***ConMed Linvatec … was recalled by Linvatec Corp. dba ConMed Linvatec in August 15, 2012. Reason: ConMed Linvatec recalled one lot of their PopLok bone Punch 3.5MM because the metal shaft diameter is 4.5mm w…. Check the official notice for the remedy. Verify recall #Z-2151-2012 with the FDA Devices before acting.

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The recall

Linvatec Corp. dba ConMed Linvatec issued this moderate-severity FDA Devices recall-ConMed Linvatec recalled one lot of their PopLok bone Punch 3.5MM because the metal shaft diameter is 4.5mm w….

Moderate
severity level: 2 units
affected scope: Class II
classification: August 15, 2012
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-2151-2012 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This FDA Devices action (record #Z-2151-2012) was formally reported on August 15, 2012, with the manufacturer initiating the action on July 6, 2012. It is classified under Moderate severity (Class II), with a current status of Terminated. Linvatec Corp. dba ConMed Linvatec is listed as the recalling firm, operating out of Largo, FL. Federal records list the affected scope as 2.

The documented reason for this recall is: ConMed Linvatec recalled one lot of their PopLok bone Punch 3.5MM because the metal shaft diameter is 4.5mm when it should have been 3.5mm. Distribution data in the federal record shows the product reached: Worldwide Distribution -- US and Korea.. 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

Related Recalls

3 from same agency

Product description

PopLok Punch labeled in part: "PKL-35M***3.5mm***QTY 1***PopLok Punch***ConMed Linvatec Biomaterials, Ltd. Hermiankatu 6-8L 33720 Tampere, FINLAND***Rx Only***ConMed Linvatec 11311 Concept Blvd Largo, FL 33773-4908 USA***Made in USA***" Intended Use: Bone Punch.

Reason for recall

ConMed Linvatec recalled one lot of their PopLok bone Punch 3.5MM because the metal shaft diameter is 4.5mm when it should have been 3.5mm.

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-2151-2012
Date reported	August 15, 2012
Date initiated	July 6, 2012
Recalling firm	Linvatec Corp. dba ConMed Linvatec
Firm location	Largo, FL
Affected scope	2
Distribution	Worldwide Distribution -- US and Korea.

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

Scale of Impact

2 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-2151-2012) 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? ▼

ConMed Linvatec recalled one lot of their PopLok bone Punch 3.5MM because the metal shaft diameter is 4.5mm when it should have been 3.5mm.

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on August 15, 2012. Severity: Moderate. Recall number: Z-2151-2012.

Where was the recalled product distributed? ▼

Distribution: Worldwide Distribution -- US and Korea..

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

Check the product description and recall number (Z-2151-2012) 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 August 15, 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.