FDA Device recall Z-2794-2015
Dynamic Locking Screw System (DLS) 3.7mm & Dynamic Locking Screw (DLS) 5.0mm
- FDA Device
- Class II
- terminated
- Published 2015-09-30
On 2015-09-30 the FDA classified a Class II recall of Dynamic Locking Screw System (DLS) 3.7mm & Dynamic Locking Screw (DLS) 5.0mm by Synthes Usa Products, citing DLS pin breakage during planned implant removal, after uneventful and successful healing of the fracture. This notice to additional consignees identified after recall Z-0390-2014,….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2794-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-08-11 |
| Published | 2015-09-30 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Synthes Usa Products |
| Distribution | US |
Product
Dynamic Locking Screw System (DLS) 3.7mm & Dynamic Locking Screw (DLS) 5.0mm; 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
DLS pin breakage during planned implant removal, after uneventful and successful healing of the fracture. This notice to additional consignees identified after recall Z-0390-2014, related to complaints of breakage located at the bottom of the screws and under the locking screw head.
Identifiers
| code_info | Part Numbers 09.213.022S 09.213.024S 09.213.026S 09.213.028S 09.213.030S 09.213.032S 09.213.034S 09.213.036S 0…Part Numbers 09.213.022S 09.213.024S 09.213.026S 09.213.028S 09.213.030S 09.213.032S 09.213.034S 09.213.036S 09.213.038S 09.213.040S 09.213.042S 09.213.044S 09.213.046S 09.213.048S 09.213.050S 09.213.052S 09.213.054S 09.213.056S 09.213.058S 09.213.060S 09.213.065S 09.213.070S 09.223.032S 09.223.034S 09.223.036S 09.223.038S 09.223.040S 09.223.042S 09.223.044S 09.223.046S 09.223.048S 09.223.050S 09.223.055S 09.223.060S 09.223.065S 09.223.070S 09.223.075S 09.223.080S 09.223.085S 09.223.090S with Lot Numbers 2799588 2799590 2801042 2801043 2802483 2803970 2806031 2809073 2809673 2812544 2813042 2813043 2813065 2814722 2815303 2822441 2822442 7802259 7802261 7804003 7813305 7833918 7883446 2799592 2799804 2801040 2801041 2802484 2803971 2806032 2809075 2809668 2809669 2810870 2810896 2811588 2814723 2815305 2822443 7764728 7769461 7802262 7804004 7804005 7813306 2798572 2798573 2798574 2801019 2803150 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2794-2015%22
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