DePuy Synthes Radiolucent Retractor, part number 387.580, lot number 3620715

FDA device recall Z-0092-2015 · posted 2014-10-20 · Terminated

Recall details

Recalling firm

Synthes, Inc.

Reason for recall

Particle residue on the instrument from adhesive tape which was used to bind the device during transport. There may be a risk of tissue reaction if a patient is exposed to latex particles from the adhesive tape, or a systemic reaction such as anaphylaxis in patients with latex allergy.

Action taken

DePuy Synthes sent an Urgent Notice Medical Device Recall letter dated October 2, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Please take the following actions: If you DO have any of the identified devices, please take the following steps: Call DePuy Synthes at 1-800-479-6329 to obtain a Return Authorization (RA) Number. Complete the Verification Section (page 3 of this letter) by checking the appropriate box indicating affected product has been located. Also, please indicate the number of devices found and note the Return Authorization Number. Please include your name, title, address, telephone number and signature in the spaces provided. Send a copy of the completed Verification Section to DePuy Synthes by: Fax: (610) 430-7083 or " Scan/email: Fieldaction@synthes.com Note: If the Verification Section 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 on page 3 of the notification. If you DO NOT have the identified product, please take the following steps: Complete the attached Verification Section (page 3 of this letter) by checking the appropriate box indicating that no affected product has been located. Please include your name, title, address, telephone number and signature in the spaces provided. This return documentation acknowledges your receipt of medical device removal information. Return the documents to DePuy Synthes by Fax: (610) 430-7083 or Scan/email: Fieldaction@sythes.com Note: If the Verification Section 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 on page 3 of the notification. If you have any questions, please call 610-719-5450, or contact your DePuy Synthes sales consultant. Thank you for your attention to this issue.

Root cause

Material/Component Contamination

Status

Terminated

Product code

GAD

Quantity affected

11

Distribution

US Distribution including the states of PA, NC, TN, NY, WI, WA and MI.

Date initiated

2014-10-02

Date posted

2014-10-20

Date terminated

2015-12-18

Location

West Chester, PA