SmartSet Endurance GMV, Gentamicin, REF 3105-040, Medium Viscosity Antibiotic Bone Cement, Sterile. SmartSet GMV Enduran

FDA device recall Z-0064-2014 · posted 2013-10-23 · Terminated

Recall details

Recalling firm

DePuy Orthopaedics, Inc.

Reason for recall

The SmartSet GMV Endurance Gentamicin Bone Cement, product ref: number 3105-040 is intended for use in indications that have not been cleared by the US FDA. The intended use stated in the IFU for the SmartSet GMV Endurance Gentamicin Bone Cement is for the fixation of prostheses to living bone in arthroplasty procedures of joints in which infection by gentamicin-sensitive organisms is a potentia

Action taken

The firm DePuy Synthes, sent an "URGENT INFORMATION-MEDICAL DEVICE RECALL NOTICE" dated September 16, 2013 to its consignees via E-mail, hand delivery or fax depending on the most appropriate delivery method for each consignees. The Urgent recall notice described the recalled product, explained the reason for the recall, and directed consignees to cease further distribution, complete the attached Reconciliation form and quarantine and return all affected products through the DePuy Orthopaedics Sales consultant, Fax 1-787-287-7681 or Email to vbaez1@its.jnj.com. Consignees were directed to maintain a copy of the notice and forward the notice if product was further distributed. Clinical questions should be addressed to DePuy Orthopaedics, Inc's Scientific Information Office at 1-888-554-2482 (M-F; 8 a.m. - 5 p.m. EDT). Recall questions or concerns should be addressed to the Quality & Compliance Supervisor, at 1-787- 272-1900 x3114 or vbaez1@its.jnj.com (MF; 8 am- 5 pm EST).

Root cause

No Marketing Application

Status

Terminated

Product code

MBB

Quantity affected

16,040 units

Distribution

Distributed in Puerto Rico and US Virgin Islands.

Date initiated

2013-09-16

Date posted

2013-10-23

Date terminated

2015-02-24

Location

Warsaw, IN