Reported Jul 27, 2016 · Terminated
Depuy Synthes Trauma- Trochanteric Fixation Nail Advanced (TFNA) Blade/Screw Guide Sleeve, Surgical Instrument Part…
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?
- Depuy Synthes Trauma- Trochanteric Fixation Nail Advanced (TFNA) Blade/Screw Guide Sleeve, Surgical Instrument Part Number ID 03.037.017
- Class I exempt Lot Numbers9066399; 9066435; 9409790; 9519308; 9620447; 9301183; 9409792; 9519303; 9641077; 9301184; 9409791; 9542998; 9641078; 9327510; 9422885; 9554330; 9651850; 9340629; 9351396; 9554329; 9604307; 9347642; 9428332; 9533341; 9661610; 9339162; 9439269; 9574931; 9734868; 9347641; 9485532; 9569618; 9704087; 9351397; 9485534; 9569617; 9734876; 9359540; 9494322; 9590744; 9661608; 9359339; 9501935; 9590747; 9371095; 9505477; 9604306 These devices are specific to the Trochanteric Fixation Nail Advanced (TFNA) system. The TFNA Proximal Femoral Nailing System is for the treatment of intramedullary fixation of proximal femoral fractures
- Lot codes and dates
- Catalog ID03.037.017
- Lot Numbers
90663999066435940979095193089620447930118394097929519303964107793011849409791954299896410789327510942288595543309651850934062993513969554329960430793476429428332953334196616109339162943926995749319734868934764194855329569618970408793513979485534956961797348769359540949432295907449661608935933995019359590747937109595054779604306
- Manufactured Date30Jul2014 -01Jul2015
- Amount recalled
- 2,064 units
Where it was sold
Why it was recalled
DePuy Synthes is initiating a voluntary medical device recall due to Blade/Screw Guide Sleeves (Part # 03.037.017) may have been manufactured with a slightly larger than specified outer diameter which could prevent the sleeve from going through the TFNA aiming arm properly, which may cause surgical delay.
This product could cause temporary or reversible health problems — stop using it.
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