RSP Humeral Socket Reamer (Size 32 SML): DJO Surgical Instruments and Instrument Cases DJO surgical Encore Medical, L.P.

FDA device recall Z-0150-2012 · posted 2011-11-02 · Terminated

Recall details

Recalling firm

Encore Medical, Lp

Reason for recall

DJO Surgical has determined that the alignment pins cannot be consistently cleaned using the technique provided in the cleaning/sterilization section of the instrument IFU.

Action taken

DJO Surgical sent an URGENT FIELD SAFETY NOTICE letter dated September 28, 2011, to all affected customers. The letter identified the product. the problem, and the action to be taken by the customer. Customers were instructed to return the RSP Humeral Socket Reamers and RSP Baseplate Rim Planers. The RSP Humeral Socket Reamers will be reworked and returned to the customer. The Baseplast Rim Planer will be replaced when a suitable design is available. During the interim until instruments are returned, the use of FMP acetabular reamers size 42mm, 43mm, 45mm (DJO PIN 803-05-226, 227, 200) for the humeral preparation was validated to be effective to prepare the humerus for the implant. Customers were instructed to immediately notify the hospitals and surgeons using these devices and document it on the Field Safety Notice Response Form. For questions regarding this recall call 512-832-9500.

Root cause

Device Design

Status

Terminated

Product code

LXH

Quantity affected

399 Reamers

Distribution

Worldwide Distribution - USA including AR, AZ, CA, CO, FL,GA, ID, IN, IL, LA, MA, MD, ME, MI, MO, NJ, NM, NY, OH, OK, PA, PR, SC, TN, TX, UT, VA, WA, and WI and Internationally toGermany, South Americ

Date initiated

2011-09-28

Date posted

2011-11-02

Date terminated

2013-03-29

Location

Austin, TX