FDA Device recall Z-0390-2014
3.7mm and 5.0mm Dynamic Locking Screw (DLS) Product Usage: 3.7mm and 5.0mm Dynamic Locking Screw (DLS) in combination with Synthes Locking…
- FDA Device
- Class II
- terminated
- Published 2013-12-04
On 2013-12-04 the FDA classified a Class II recall of 3.7mm and 5.0mm Dynamic Locking Screw (DLS) Product Usage: 3.7mm and 5.0mm Dynamic Locking Screw (DLS) in combination with Synthes Locking… by Synthes Usa Hq, citing all lots of 3.7mm and 5.0mm Dynamic Locking Screw (DLS) were recalled due to complaints of breakages at the distal tip of the pin identified after successful healing and during pl….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0390-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-07-22 |
| Published | 2013-12-04 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Synthes Usa Hq |
| Distribution | US |
Product
3.7mm and 5.0mm Dynamic Locking Screw (DLS) Product Usage: 3.7mm and 5.0mm Dynamic Locking Screw (DLS) in combination with Synthes Locking Compression Plates (LCP) are intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and for the fixation of non-unions and malunions.
Reason
All lots of 3.7mm and 5.0mm Dynamic Locking Screw (DLS) were recalled due to complaints of breakages at the distal tip of the pin identified after successful healing and during planned removal of the device.
Identifiers
| code_info | All lots of parts 09.213.022S - 09.213.070S, and 09.223.032S- 09.223.090S. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
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FDA Device · Class II · 2013-12-18 · Synthes Usa Hq - Synthes TomoFix Plates The Synthes J5606-C TomoFix Osteotomy System is used for open and closed wedge osteotomies of the medial proximal ti…
FDA Device · Class II · 2013-12-18 · Synthes Usa Hq - Synthes Soft Tissue Retractor Small Extendible
FDA Device · Class II · 2013-12-11 · Synthes Usa Hq - Titanium Trochanteric Fixation Nail (TFN)System Intended to treat stable and unstable fractures of the proximal femur
FDA Device · Class II · 2013-12-11 · Synthes Usa Hq
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0390-2014%22
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