DePuy Custom Implant Devices Packaging: Packaging was not standardized on customs, it was dependant on the geometry of t

FDA device recall Z-2217-2012 · posted 2012-08-16 · Terminated

Recall details

Recalling firm

DePuy Orthopaedics, Inc.

Reason for recall

In connection with a Warning Letter received from the U.S. Food & Drug Administration on December 9, 2011, DePuy Orthopaedics is taking steps to retrieve custom device implants that surgeons may have ordered from DePuy Orthopaedics, but not implanted. DePuy Orthopaedics received a Warning Letter from the FDA on December 9, 2011 regarding custom device implants. DePuy Orthopaedics has discontinue

Action taken

DePuy sent a written communication letter dated July 31, 2012 to all consignees. The communication to the hospital customers who received the devices includes a "Surgeon Letter" with instructions to provide the surgeon letter to the Surgeon users. All DePuy Distributors will be notified via email. The sales representatives notified the hospital and surgeons either by mail or in person with a written communication. The letters identified the affected product, problem and actions to be taken. Customers are instructed to complete the attached Roponse form and return to fax number 574-371-4939 or email: kseppa@its.jnj.com. The sales representatives are expected to aid customers in returning of unused Custom Device implants, if needed. The devices can be returned through the normal DePuy Returns process, to attention of "Returns" and marked "Custom Returns" on the outside of the box. Questions Regarding the Removal Questions regarding the removal may be directed to the following DePuy representatives -Questions about removal information provided: Katie Seppa, Manager of Post-Market Surveillance, 574-372-7333 (M-F; 8 am 5 pm EDT) -Clinical related questions from surgeons: Direct to DePuys Scientific Information Office at 1-888-554-2482 (M-F; 8 am-5 pm EDT)

Root cause

PMA

Status

Terminated

Product code

OOM

Quantity affected

8338

Distribution

US Nationwide Distribution - including the states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, HI, IA, ID, IL, IN, KS, KY, LA, MA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY

Date initiated

2012-07-31

Date posted

2012-08-16

Date terminated

2014-01-13

Location

Warsaw, IN