Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported February 26, 2014
Synthes Driving Cap/Threaded Both parts are intended for use in the Tibia system, LFN and RAFN systems. Their function is to insert a nail. The Synthes Driving Cap/Threaded is threaded into the insertion handle and secured with a wrench. If desired, the nail can then be inserted using light hammer blows.
The Synthes Driving Cap/Threaded can bind in the IM Nail Radiolucent Insertion Handles when assembled becoming difficult to separate.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Synthes, Inc. recalled Synthes Driving Cap/Threaded Both parts are intended for use in the Tibia system, LFN … - a moderate-severity action.
Synthes Driving Cap/Threaded Both parts are intended for use in the Tibia system, LFN … was recalled by Synthes, Inc. in February 26, 2014. Reason: The Synthes Driving Cap/Threaded can bind in the IM Nail Radiolucent Insertion Handles when assembled becomin…. Check the official notice for the remedy. Verify recall #Z-1057-2014 with the FDA Devices before acting.
The recall
Synthes, Inc. issued this moderate-severity FDA Devices recall-The Synthes Driving Cap/Threaded can bind in the IM Nail Radiolucent Insertion Handles when assembled becomin….
- Moderate
- severity level
- 143 units
- affected scope
- Class II
- classification
- February 26, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1057-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1057-2014) was formally reported on February 26, 2014, with the manufacturer initiating the action on January 7, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Synthes, Inc. is listed as the recalling firm, operating out of West Chester, PA. Federal records list the affected scope as 143.
The documented reason for this recall is: The Synthes Driving Cap/Threaded can bind in the IM Nail Radiolucent Insertion Handles when assembled becoming difficult to separate. Distribution data in the federal record shows the product reached: USA (nationwide) Distribution.. 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
143
Related Recalls
6
3 from same agency
Product description
Synthes Driving Cap/Threaded Both parts are intended for use in the Tibia system, LFN and RAFN systems. Their function is to insert a nail. The Synthes Driving Cap/Threaded is threaded into the insertion handle and secured with a wrench. If desired, the nail can then be inserted using light hammer blows.
Reason for recall
The Synthes Driving Cap/Threaded can bind in the IM Nail Radiolucent Insertion Handles when assembled becoming difficult to separate.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1057-2014 |
| Date reported | February 26, 2014 |
| Date initiated | January 7, 2014 |
| Recalling firm | Synthes, Inc. |
| Firm location | West Chester, PA |
| Affected scope | 143 |
| Distribution | USA (nationwide) Distribution. |
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-1057-2014) 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? ▼
Synthes Driving Cap/Threaded Both parts are intended for use in the Tibia system, LFN and RAFN systems. Their function is to insert a nail. The Synthes Driving Cap/Threaded is threaded into the insertion handle and secured with a wrench. If desired, the nail can then be inserted using light hammer blows.. Recalled by Synthes, Inc.. Units affected: 143.
Why was this product recalled? ▼
The Synthes Driving Cap/Threaded can bind in the IM Nail Radiolucent Insertion Handles when assembled becoming difficult to separate.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 26, 2014. Severity: Moderate. Recall number: Z-1057-2014.
Where was the recalled product distributed? ▼
Distribution: USA (nationwide) Distribution..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1057-2014) 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 February 26, 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.