Synthes Cranial Flap Tube Clamp and Crimping Device Product Usage: The Synthes Cranial Flap Tube Clamp System is intende

FDA device recall Z-2811-2015 · posted 2015-09-23 · Terminated

Recall details

Recalling firm

Synthes (USA) Products LLC

Reason for recall

The Synthes Cranial Flap Tube Clamp and Crimping Device for Cranial Tube Clamp had been labeled MR Safe although they do not have the testing protocols currently required to designate them as MR Safe.

Action taken

DePuy Synthes sent an URGENT:FIELD SAFETY NOTIFICATION / MEDICAL DEVICE LABELING CORRECTION letter, dated August 31, 2015 to affected customers. The letter identified affected product, problem and actions to be taken. Customers were instructed to: "Update and review the package insert (GP1345-D). " Discard outdated package insert noted in the table above. " Forward this Field Safety Notification to anyone in your facility that needs to be informed, especially personnel that conduct MR testing. " If the package insert has been forwarded to another facility, contact that facility. " Complete the attached Verification Section (page 3 of this notification). Please include your name, title, address, telephone number and signature in the spaces provided. Send a copy of the completed Verification Section by, Fax: 877-884-7821 or Scan/email: Synthes3911@stericycle.com " If the Verification Form is answered on behalf of more than one facility and/or individual, please clearly indicate the name and address of the facility and/or individual in page three (3) of this notification. " Maintain a copy of this notice. For questions call 610-719-5450.

Root cause

Labeling False and Misleading

Status

Terminated

Product code

GXN

Quantity affected

105882

Distribution

US Nationwide and internationally, including Canada.

Date initiated

2015-08-31

Date posted

2015-09-23

Date terminated

2016-08-18

Location

West Chester, PA

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