Reported Mar 18, 2015 · Terminated
Synthes Inserter for Titanium Elastic Nails; The Inserter for Titanium Elastic Nails (TEN) is intended for fixation of…
Synthes, Inc.
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, Inc. · 1302 Wrights Ln E · West Chester, PA · 19380-3417
Is this the product you have?
- Synthes Inserter for Titanium Elastic Nails; The Inserter for Titanium Elastic Nails (TEN) is intended for fixation of diaphyseal fractures where the canal is narrow or flexibility of the implant is paramount
- This includeslower extremity fractures in pediatric and small-statured patients and upper extremity fractures in patients. This system is also intended to treat metaphyseal and episphyseal fractures, such as radial neck fractures, and is intended for fixation of small long bones, such as carpal and tarsal bones. In pediatric applications, the flexibility of the elastic nail allows it to be inserted at a point which avoids disruption of the bone growth plate
- Lot codes and dates
- Part Number359.219
- Sold As Lot Numbers4825384; (Manufacturing
111 of 111 codes
432165943404514466686447090054964555700078571848557184865718487190433930056743005675300931230206743025607305119030546083065013306956630846373098634312143832329313242304326271233010173325276338258334103303430483349358835049963524633361911936260553659645370661137978357505411756599076011127619995767074176756237727696777449178106497845943787422478960757979727479646348260214911859491186049690144971314506641750420015066418
- Lot NumbersA8NA430)
111 of 111 codes
109560710956071121876112187616417001806500181105618110591813900190433930056743005675300931230206743025607305119030546083065013306956630846373098634312143832329313242304326271233010173325276338258334103303430483349358835049963524633361911936260553659645370661137978357505411756599076011127619995767074176756237727696777449178106497845943787422478960757979727800013680025188002635800263580045388004538800517980061038006214
- Amount recalled
- 1550
Where it was sold
- Nationwide
Why it was recalled
The Inserter has the potential for mechanical failures such as breakage of the main shaft of the Inserter for the TEN, malfunction of the chuck of the Inserter for the TEN in the form of the chuck getting stuck/jammed, breakage of the cross bar of the Inserter for the TEN.
This product could cause temporary or reversible health problems — stop using it.
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