Z-2214-2016Class II

Depuy Synthes Trauma- Trochanteric Fixation Nail Advanced (TFNA) Blade/Screw Guide Sleeve, Surgical...

Name: Z-2214-2016 Depuy Synthes Trauma- Trochanteric Fixation Nail Advanced (TFNA) Blade/Screw Guide Sleeve, Surgical...
Creator: Synthes (USA) Products LLC
Published: 2016-06-07
License: https://open.fda.gov/license/

Synthes (USA) Products LLC / initiated 2016-06-07 / Terminated / root cause: manufacturing process

FDA source

Synthes (USA) Products LLC began a recall of Depuy Synthes Trauma- Trochanteric Fixation Nail Advanced (TFNA) Blade/Screw Guide Sleeve, Surgical Instrument Part Number ID 03.037.017, Class I exempt Lot... on 2016-06-07. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2214-2016
Classification: Class II
Status: Terminated
Initiated: 2016-06-07
Posted: 2016-07-15
Terminated: 2017-04-25
Recalling firm: Synthes (USA) Products LLC
Product: 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 code: FZX Guide, Surgical, Instrument
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: DePuy Synthes sent an Urgent Notice Medical Device Recall letter to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to conduct functional testing to inspect the instrument to determine if the Guide Sleeve is able to fit through the aiming arm properly. Customers were asked to only return the device if the product does not pass. Customers with questions were instructed to call 610-719-5450 or contact their DePuy Synthes Sales Consultant.
Quantity in commerce: 2,064 units
Distribution: 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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2214-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2214-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-27	2016-07-15

Product code FZX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)