DePuy Synthes 6.5 mm Titanium Recon Screws w/T25 Stardrive (70mm, 75mm, 80mm, 85mm, 90mm, 95mm, 105mm); part of the Expe

FDA device recall Z-1915-2015 · posted 2015-06-26 · Terminated

Recall details

Recalling firm

Synthes, Inc.

Reason for recall

certain lots of the Titanium Recon Screws (6.5mm ) were found to contain the incorrect insert GP0760-A (Synthes Titanium Buttress Locking Plate System), instead of the correct insert GP0706-E (Synthes Titanium Intramedullary Nails and Components).

Action taken

DePuy Synthes sent an Urgent Medical Device Safety Notification, dated May 27, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Actions Required: Please take the following actions: Review the information listed in this notification. Forward this notice to anyone in your facility that needs to be informed. 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: (888) 912-2182 or Scan/email: Synthes4844@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. If you have any questions, please call (610)719-5450. Thank you for your attention to this issue.

Root cause

Process control

Status

Terminated

Product code

HSB

Quantity affected

276

Distribution

Nationwide Distribution.

Date initiated

2015-05-27

Date posted

2015-06-26

Date terminated

2015-12-18

Location

West Chester, PA

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