Dynamic Locking Screw System — Class II medical device recall Z-2794-2015

Terminated recall by Synthes (USA) Products LLC, reported 2015-09-30, distributed nationwide. DLS pin breakage during planned implant removal, after uneventful and successful healing of the fracture. This

Recall number	`Z-2794-2015`
Product type	Medical device
Classification	Class II
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	Synthes (USA) Products LLC, West Chester, PA, United States
Recall initiated	2015-08-11
Classified	2015-09-18
Reported by FDA	2015-09-30
Terminated	2016-08-18
Distributed	Nationwide (US)
Quantity	40,038
Reason classes	device malfunction
Lot numbers	`2748748`, `2748939`, `2748940`, `2748943`, `2748945`, `2748947`, `2748971`, `2748972`, `2748973`, `2748974`, `2748975`, `2748976`, `2748977`, `2748978`, `2749819`, `2749820`, `2749821`, `2749825`, `2749827`, `2749829`, `2749831`, `2751623`, `2751624`, `2751625`, `2751626`, `2751632`, `2763692`, `2763694`, `2773533`, `2773534`, `2773536`, `2773539`, `2774563`, `2774564`, `2778498`, `2778507`, `2778508`, `2778519`, `2778525`, `2778526` and 460 more
Model 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` and 15 more

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 for recall

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2794-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.