Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported March 27, 2013
Extremity Medical - Disposable Orthopedic Surgical Instrument - 1.6 mm Guidewire - Reference Number 101-00006 - Non-Sterile. Contained in Extremity Medical Surgical Kits including CompressX, Hallu.X, IO Fix and XMCP. Used in the selection of screw size when used with appropriate depth gauge.
The 1.6 mm Guidewire is undersized up to 2 mm in length. When used with the depth gauge, the measurement reading will not correspond with the desired screw length. The selected sc…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Extremity Medical LLC recalled Extremity Medical - Disposable Orthopedic Surgical Instrument - 1.6 mm Guidewire - Refere… - a moderate-severity action.
Extremity Medical - Disposable Orthopedic Surgical Instrument - 1.6 mm Guidewire - Refere… was recalled by Extremity Medical LLC in March 27, 2013. Reason: The 1.6 mm Guidewire is undersized up to 2 mm in length. When used with the depth gauge, the measurement read…. Check the official notice for the remedy. Verify recall #Z-0952-2013 with the FDA Devices before acting.
The recall
Extremity Medical LLC issued this moderate-severity FDA Devices recall-The 1.6 mm Guidewire is undersized up to 2 mm in length. When used with the depth gauge, the measurement read….
- Moderate
- severity level
- 238 units
- affected scope
- Class II
- classification
- March 27, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0952-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0952-2013) was formally reported on March 27, 2013, with the manufacturer initiating the action on January 10, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. Extremity Medical LLC is listed as the recalling firm, operating out of Parsippany, NJ. Federal records list the affected scope as 238 units.
The documented reason for this recall is: The 1.6 mm Guidewire is undersized up to 2 mm in length. When used with the depth gauge, the measurement reading will not correspond with the desired screw length. The selected screw size based on the depth gauge readin… Distribution data in the federal record shows the product reached: Worldwide Distribution-USA including the states of Florida, Pennsylvania, New Hampshire, Oklahoma, California, Maryland, Arizona, Ohio, North Carolina, Texas, Virginia, Illinois, New York and Tennessee, and the countrie…. 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
238 units
Related Recalls
6
3 from same agency
Product description
Extremity Medical - Disposable Orthopedic Surgical Instrument - 1.6 mm Guidewire - Reference Number 101-00006 - Non-Sterile. Contained in Extremity Medical Surgical Kits including CompressX, Hallu.X, IO Fix and XMCP. Used in the selection of screw size when used with appropriate depth gauge.
Reason for recall
The 1.6 mm Guidewire is undersized up to 2 mm in length. When used with the depth gauge, the measurement reading will not correspond with the desired screw length. The selected screw size based on the depth gauge reading will be about 2 mm longer than intended.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0952-2013 |
| Date reported | March 27, 2013 |
| Date initiated | January 10, 2013 |
| Recalling firm | Extremity Medical LLC |
| Firm location | Parsippany, NJ |
| Affected scope | 238 units |
| Distribution | Worldwide Distribution-USA including the states of Florida, Pennsylvania, New Hampshire, Oklahoma, California, Maryland, Arizona, Ohio, North Carolina, Texas, Virginia, Illinois, New York and Tennessee, and the countries of Australia, Belg… |
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-0952-2013) 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? ▼
Extremity Medical - Disposable Orthopedic Surgical Instrument - 1.6 mm Guidewire - Reference Number 101-00006 - Non-Sterile. Contained in Extremity Medical Surgical Kits including CompressX, Hallu.X, IO Fix and XMCP. Used in the selection of screw size when used with appropriate depth gauge.. Recalled by Extremity Medical LLC. Units affected: 238 units.
Why was this product recalled? ▼
The 1.6 mm Guidewire is undersized up to 2 mm in length. When used with the depth gauge, the measurement reading will not correspond with the desired screw length. The selected screw size based on the depth gauge reading will be about 2 mm longer than intended.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 27, 2013. Severity: Moderate. Recall number: Z-0952-2013.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution-USA including the states of Florida, Pennsylvania, New Hampshire, Oklahoma, California, Maryland, Arizona, Ohio, North Carolina, Texas, Virginia, Illinois, New York and Tennessee, and the countries of Australia, Belgium, Israel, Netherlands and United Kingdom..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0952-2013) 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 March 27, 2013. 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.