Reported Sep 30, 2015 · Terminated
Dynamic Locking Screw System (DLS) 3.7mm & Dynamic Locking Screw (DLS) 5.0mm; intended for use in long bone fractures,…
Synthes (USA) Products LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Synthes (USA) Products LLC · 1301 Goshen Pkwy · West Chester, PA · 19380-5986
Is this the product you have?
- 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.
- Lot codes and dates
- Part Numberswith Lot Numbers
09.213.022S09.213.024S09.213.026S09.213.028S09.213.030S09.213.032S09.213.034S09.213.036S09.213.038S09.213.040S09.213.042S09.213.044S09.213.046S09.213.048S09.213.050S09.213.052S09.213.054S09.213.056S09.213.058S09.213.060S09.213.065S09.213.070S09.223.032S09.223.034S09.223.036S09.223.038S09.223.040S09.223.042S09.223.044S09.223.046S09.223.048S09.223.050S09.223.055S09.223.060S09.223.065S09.223.070S09.223.075S09.223.080S09.223.085S09.223.090S
977 of 977 codes
279958827995902801042280104328024832803970280603128090732809673281254428130422813043281306528147222815303282244128224427802259780226178040037813305783391878834462799592279980428010402801041280248428039712806032280907528096682809669281087028108962811588281472328153052822443776472877694617802262780400478040057813306279857227985732798574280101928031502803361280479928090772810267281026828147242814725281530728153082815837
- Part Numbers
- Amount recalled
- 40038
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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