Synthes Ti Button Plate 7 Holes, Fastener, Fixation, nondegradable, Soft Tissue

FDA device recall Z-2138-2016 · posted 2016-07-07 · Terminated

Recall details

Recalling firm

Synthes (USA) Products LLC

Reason for recall

DePuy Synthes is voluntarily initiating a recall due to affected devices being distributed and or labeled with MR Safety information that does not meet the current ASTM standard.

Action taken

Synthes mailed to customers (Hospital Personnel and Sales Consultants) an URGENT FIELD SAFETY NOTIFICATION letter informing them the insert they received, which contained incorrect MR Safety Information, does not meet the current ASTM standards. Customers were asked to review the package insert provided with the notification letter, discard the outdated package insert, complete the attached verification Section (page 3 of this notification) and send a copy of the completed Verification Section by Fax: 844-782-5568 or scan/email: Synthes7923@stericycle.com. For further questions call (610) 719-6500.

Root cause

Under Investigation by firm

Status

Terminated

Product code

MBI

Quantity affected

6,255 units

Distribution

USA Distribution to the states of : AK,AL,AR,AZ,CA,CH,CO,CT,DC,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,ON,OR,PA,RI,SC,SD,TN,TX,UT,VA,VT,WA,WI, & WV

Date initiated

2016-05-31

Date posted

2016-07-07

Date terminated

2017-04-25

Location

West Chester, PA

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