Synthes, Inc. Recall: Pull Reduction Device For 4.3mm Percutaneous Drill Guide; The pull r
Synthes, Inc. Recall: Pull Reduction Device For 4.3mm Percutaneous Drill Guide; The pull r is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Synthes, Inc.; Product: Pull Reduction Device For 4.3mm Percutaneous Drill Guide; The pull reduction device with quick coupling is placed through t
| Recalling firm | Synthes, Inc. |
|---|---|
| Product | 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. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | Worldwide Distribution-US (nationwide) and internationlly to Canada |
| Recall initiated | 20150528 |
| Recall number | Z-1799-2015 |
| Category | device |
| State | PA |
| Country | United States |
$29/mo
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