Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported October 29, 2014
Symmetric Total Knee Femoral Components Product Usage: Symmetric Total Knee Femoral Component is intended for use with Signal Medical Corp. Total Knee System for cemented use INA Total Knee Replacement. The femoral component is made of cobalt chromium alloy (ASTM F75).
Packaging of a device was compromised
Signal Medical Corporation recalled Symmetric Total Knee Femoral Components Product Usage: Symmetric Total Knee Femoral C… - a moderate-severity action.
Symmetric Total Knee Femoral Components Product Usage: Symmetric Total Knee Femoral C… was recalled by Signal Medical Corporation in October 29, 2014. Reason: Packaging of a device was compromised. Check the official notice for the remedy. Verify recall #Z-0111-2015 with the FDA Devices before acting.
The recall
Signal Medical Corporation issued this moderate-severity FDA Devices recall-Packaging of a device was compromised.
- Moderate
- severity level
- 41 units
- affected scope
- Class II
- classification
- October 29, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0111-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0111-2015) was formally reported on October 29, 2014, with the manufacturer initiating the action on September 30, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Signal Medical Corporation is listed as the recalling firm, operating out of Marysville, MI. Federal records list the affected scope as 41.
The documented reason for this recall is: Packaging of a device was compromised Distribution data in the federal record shows the product reached: Worldwide Distribution - US (Nationwide) in the state of: MO and internationally to: Panama.. 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
41
Related Recalls
6
3 from same agency
Product description
Symmetric Total Knee Femoral Components Product Usage: Symmetric Total Knee Femoral Component is intended for use with Signal Medical Corp. Total Knee System for cemented use INA Total Knee Replacement. The femoral component is made of cobalt chromium alloy (ASTM F75).
Reason for recall
Packaging of a device was compromised
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0111-2015 |
| Date reported | October 29, 2014 |
| Date initiated | September 30, 2014 |
| Recalling firm | Signal Medical Corporation |
| Firm location | Marysville, MI |
| Affected scope | 41 |
| Distribution | Worldwide Distribution - US (Nationwide) in the state of: MO and internationally to: Panama. |
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-0111-2015) 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? ▼
Symmetric Total Knee Femoral Components Product Usage: Symmetric Total Knee Femoral Component is intended for use with Signal Medical Corp. Total Knee System for cemented use INA Total Knee Replacement. The femoral component is made of cobalt chromium alloy (ASTM F75).. Recalled by Signal Medical Corporation. Units affected: 41.
Why was this product recalled? ▼
Packaging of a device was compromised
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 29, 2014. Severity: Moderate. Recall number: Z-0111-2015.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - US (Nationwide) in the state of: MO and internationally to: Panama..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0111-2015) 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 October 29, 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.