Malleable C- Retractor, Part Number 397.232, used to provide retraction of the soft tissues during use of trocar instrum

FDA device recall Z-0973-2015 · posted 2015-01-14 · Terminated

Recall details

Recalling firm

Synthes, Inc.

Reason for recall

Potential failure and/or corrosion of the internal spring of the retractor, which may have been manufactured from an incorrect material. Surgical delay may occur. Spring particles could transfer from the instrument to the patient, and may lead to an adverse tissue reaction and/or infection.

Action taken

The firm, DePuy Synthes, sent an "URGENT NOTICE: MEDICAL DEVICE RECALL" letter dated December 15, 2014, to its end users and sales consultants. The letter identified the product, problem, and actions to be taken. The End users/sales staff were instructed to immediately remove affected stock from inventory; call DePuy Synthes at 1-800-479-6329 to obtain a Return Authorization (RA) Number; complete and return the attached Verification Section to DePuy Synthes via fax: 866-827-3421 or Scan/email: Synthes8645@stericycly.com, even if you do not have any of the affected product, and return any affected devices to Synthes. If you have any questions, please call 610-719-5450 or contact your DePuy Synthes sales consultant.

Root cause

Component design/selection

Status

Terminated

Product code

GAD

Quantity affected

1762

Distribution

Worldwide Distribution: US (nationwide) and internationally to Canada.

Date initiated

2014-12-15

Date posted

2015-01-14

Date terminated

2016-08-18

Location

West Chester, PA