Recall Z-2138-2016 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
Synthes (USA) Products LLC
Synthes Ti Button Plate 7 Holes, Fastener, Fixation, nondegradable, Soft Tissue
| Date | Jul 7, 2016 (initiated May 31, 2016) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Under Investigation by firm |
| Action | 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 Customers were asked to review the package insert provided with the notification letter, discard the outdated package insert, complete the attached verification Section (page 3 of this notification) and send a copy of the completed Verification Section by Fax: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 |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K994364 | SYNTHES BUTTON PLATE Synthes (Usa), Mar 15, 2000 |