Synthes Ti Button Plate 7 Holes, Fastener, Fixation, nondegradable, Soft Tissue
FDA Recall Z-2138-2016 · Posted 2016-07-07
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Recalling FirmSynthes (USA) Products LLC
Recall StatusTerminated
Product CodeMBI
Date Initiated2016-05-31
Date Terminated2017-04-25
Product Quantity6,255 units
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.
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 Customers were asked to review the package insert provided with the notification letter, discard the outdated package insert, complete the attached verification Section (page 3 of this notification) and send a copy of the completed Verification Section by Fax: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: [email protected]. For further questions call (610) 719-6500.
Root Cause
Under Investigation by firm
Distribution Pattern
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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