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

FDA device recall Z-2214-2016 · posted 2016-07-15 · Terminated

Recall details

Recalling firm

Synthes (USA) Products LLC

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.

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

FZX

Quantity affected

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

Date initiated

2016-06-07

Date posted

2016-07-15

Date terminated

2017-04-25

Location

West Chester, PA