ModerateClass IITerminated

FDA Devices recall · Reported May 7, 2014

The Osteo-Clage System consists of stainless steel cable/sleeves and compression plates. . 2.0 mm x 850mm SS Cable/Sleeve; Part Number 01-0020-S 2.0 mm SS Sleeve Only; Part Number 01-0022-S 8, 7 hole, SS compression plate; Part Number 02-2007-S 10, 9 hole, SS compression plate; Part Number 02-2009-S Product Usage: The Osteo-Clage Stainless Steel Bone Plate is an implantable straight, rigid stainless steel plate. It is used in conjunction with 4.5mm Cortical bone screws to provide com

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on May 7, 2014. Severity: Moderate. Recall number: Z-1515-2014.

Q: Where was the recalled product distributed?

Distribution: US Nationwide Distribution - in the states of CA, CO, FL, GA, LA, MI, MN, MO, OH, OR, PA, PR, TX, UT, VA, WA and WY. Product was distributed outside the US to: Australia, China, Figi, France, Great Britain, Italy, Japan, Korea, Maylasia, Sweden, South Africa, Spain..

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

Check the product description and recall number (Z-1515-2014) 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.

Manufacturing of these devices with a grade of stainless steel that is not within specifications.

Recall #: Z-1515-2014
Affected scope: 141 units in the US; 294 units outside the US.
Initiated: March 26, 2014

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

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Acumed LLC recalled The Osteo-Clage System consists of stainless steel cable/sleeves and compression plates. … - a moderate-severity action.

The Osteo-Clage System consists of stainless steel cable/sleeves and compression plates. … was recalled by Acumed LLC in May 7, 2014. Reason: Manufacturing of these devices with a grade of stainless steel that is not within specifications.. Check the official notice for the remedy. Verify recall #Z-1515-2014 with the FDA Devices before acting.

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The recall

Acumed LLC issued this moderate-severity FDA Devices recall-Manufacturing of these devices with a grade of stainless steel that is not within specifications..

Moderate
severity level: 141 units
affected scope: Class II
classification: May 7, 2014
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-1515-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This FDA Devices action (record #Z-1515-2014) was formally reported on May 7, 2014, with the manufacturer initiating the action on March 26, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Acumed LLC is listed as the recalling firm, operating out of Hillsboro, OR. Federal records list the affected scope as 141 units in the US; 294 units outside the US..

The documented reason for this recall is: Manufacturing of these devices with a grade of stainless steel that is not within specifications. Distribution data in the federal record shows the product reached: US Nationwide Distribution - in the states of CA, CO, FL, GA, LA, MI, MN, MO, OH, OR, PA, PR, TX, UT, VA, WA and WY. Product was distributed outside the US to: Australia, China, Figi, France, Great Britain, Italy, J…. 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

141 units in the US; 294 units outside the US.

Related Recalls

3 from same agency

Product description

The Osteo-Clage System consists of stainless steel cable/sleeves and compression plates. . 2.0 mm x 850mm SS Cable/Sleeve; Part Number 01-0020-S 2.0 mm SS Sleeve Only; Part Number 01-0022-S 8, 7 hole, SS compression plate; Part Number 02-2007-S 10, 9 hole, SS compression plate; Part Number 02-2009-S Product Usage: The Osteo-Clage Stainless Steel Bone Plate is an implantable straight, rigid stainless steel plate. It is used in conjunction with 4.5mm Cortical bone screws to provide compression across bone fractures. The Osteo-Clage Cerclage Wire Crimp sleeve is used in conjunction with the bone plate in cerclage fixation procedures

Reason for recall

Manufacturing of these devices with a grade of stainless steel that is not within specifications.

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-1515-2014
Date reported	May 7, 2014
Date initiated	March 26, 2014
Recalling firm	Acumed LLC
Firm location	Hillsboro, OR
Affected scope	141 units in the US; 294 units outside the US.
Distribution	US Nationwide Distribution - in the states of CA, CO, FL, GA, LA, MI, MN, MO, OH, OR, PA, PR, TX, UT, VA, WA and WY. Product was distributed outside the US to: Australia, China, Figi, France, Great Britain, Italy, Japan, Korea, Maylasi…

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

Scale of Impact

141 units in the US; 294 units outside the US. 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-1515-2014) 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? ▼

Manufacturing of these devices with a grade of stainless steel that is not within specifications.

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on May 7, 2014. Severity: Moderate. Recall number: Z-1515-2014.

Where was the recalled product distributed? ▼

Distribution: US Nationwide Distribution - in the states of CA, CO, FL, GA, LA, MI, MN, MO, OH, OR, PA, PR, TX, UT, VA, WA and WY. Product was distributed outside the US to: Australia, China, Figi, France, Great Britain, Italy, Japan, Korea, Maylasia, Sweden, South Africa, Spain..

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

Check the product description and recall number (Z-1515-2014) 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 May 7, 2014. 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.