Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported June 24, 2015
Pull Reduction Device For 4.3mm Percutaneous Drill Guide; The pull reduction device with quick coupling is placed through the guide sleeve and plate holes to pull or push bone fragments relative to the plate. This instrument can be used for: Minor Varus-valgus adjustments (approximately 2¿ - 4¿), Translational adjustments, Stabilization of plate bone orientation during insertion of the first screws, alignment of segmental fragments and pre-drilling dense or thick cortical bone before placing a 5
Certain affected parts and lots of the Pull Reduction Devices may have been manufactured to an incorrect hardness specification which could result in intraoperative breakage.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Synthes, Inc. recalled Pull Reduction Device For 4.3mm Percutaneous Drill Guide; The pull reduction device with … - a moderate-severity action.
Pull Reduction Device For 4.3mm Percutaneous Drill Guide; The pull reduction device with … was recalled by Synthes, Inc. in June 24, 2015. Reason: Certain affected parts and lots of the Pull Reduction Devices may have been manufactured to an incorrect hard…. Check the official notice for the remedy. Verify recall #Z-1799-2015 with the FDA Devices before acting.
The recall
Synthes, Inc. issued this moderate-severity FDA Devices recall-Certain affected parts and lots of the Pull Reduction Devices may have been manufactured to an incorrect hard….
- Moderate
- severity level
- Class II
- classification
- June 24, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1799-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1799-2015) was formally reported on June 24, 2015, with the manufacturer initiating the action on May 28, 2015. 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 3747 US, 19 Foreign.
The documented reason for this recall is: Certain affected parts and lots of the Pull Reduction Devices may have been manufactured to an incorrect hardness specification which could result in intraoperative breakage. Distribution data in the federal record shows the product reached: Worldwide Distribution-US (nationwide) and internationlly to Canada. 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
3747 US, 19 Foreign
Related Recalls
6
3 from same agency
Product description
Pull Reduction Device For 4.3mm Percutaneous Drill Guide; The pull reduction device with quick coupling is placed through the guide sleeve and plate holes to pull or push bone fragments relative to the plate. This instrument can be used for: Minor Varus-valgus adjustments (approximately 2¿ - 4¿), Translational adjustments, Stabilization of plate bone orientation during insertion of the first screws, alignment of segmental fragments and pre-drilling dense or thick cortical bone before placing a 5.0 mm locking screw.
Reason for recall
Certain affected parts and lots of the Pull Reduction Devices may have been manufactured to an incorrect hardness specification which could result in intraoperative breakage.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1799-2015 |
| Date reported | June 24, 2015 |
| Date initiated | May 28, 2015 |
| Recalling firm | Synthes, Inc. |
| Firm location | West Chester, PA |
| Affected scope | 3747 US, 19 Foreign |
| Distribution | Worldwide Distribution-US (nationwide) and internationlly to Canada |
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-1799-2015) 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? ▼
Pull Reduction Device For 4.3mm Percutaneous Drill Guide; The pull reduction device with quick coupling is placed through the guide sleeve and plate holes to pull or push bone fragments relative to the plate. This instrument can be used for: Minor Varus-valgus adjustments (approximately 2¿ - 4¿), Translational adjustments, Stabilization of plate bone orientation during insertion of the first screws, alignment of segmental fragments and pre-drilling dense or thick cortical bone before placing a 5.0 mm locking screw.. Recalled by Synthes, Inc.. Units affected: 3747 US, 19 Foreign.
Why was this product recalled? ▼
Certain affected parts and lots of the Pull Reduction Devices may have been manufactured to an incorrect hardness specification which could result in intraoperative breakage.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 24, 2015. Severity: Moderate. Recall number: Z-1799-2015.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution-US (nationwide) and internationlly to Canada.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1799-2015) 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 June 24, 2015. 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.