Synthes (USA) Products LLC: Medical Device Recall in 2016 - (Recall #: Z-2214-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

Depuy Synthes Trauma- Trochanteric Fixation Nail Advanced (TFNA) Blade/Screw Guide Sleeve, Surgical Instrument Part Number ID 03.037.017, Class I exempt Lot Numbers: 9066399; 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

Product Classification:

Class II

Date Initiated: June 7, 2016

Date Posted: July 27, 2016

Recall Number: Z-2214-2016

Event ID: 74415

Reason for Recall:

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.

Status: Terminated

Product Quantity: 2,064 units

Code Information:

Catalog ID: 03.037.017 Lot Numbers: 9066399; 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 Manufactured Date : 30Jul2014 -01Jul2015

Distribution Pattern:

Nationwide Distribution to AK,AL,AR,AZ,CA,CO,CT,DE,FL,GA,HI,IA,ID,IL,IN,KS,KY,LA,MA,MD,ME,MI,MN,MO,MS,MT,NC,ND,NE,NH,NJ,NM,NV,NY,OH,OK,OR,PA,PR,RI,SC,SD,TN,TX,UT,VA,VT,WA,WI,WV, and WY

Voluntary or Mandated:

Voluntary: Firm initiated