Devices

RSP Humeral Socket Reamer (Size 32 SML)

Model / Serial
All lots are being recalled. DJO Surgical Part Number 804-02-013, 804-02-014, and 804-02-015
Product Classification
Orthopedic Devices
Device Class
1
Implanted device?
No
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 America, Italy, Saudi Arabia, United Kingdom, and Canada.
Product Description
RSP Humeral Socket Reamer (Size 32 SML): || DJO Surgical Instruments and Instrument Cases || DJO surgical || Encore Medical, L.P. 9800 Metric Blvd, Austin, TX 78758 || Contact information: DJO Surgical, ATTN: Customer Service, 9800 Metric Blvd, Austin, TX 78758, 1-800-456-8696. || The product is intended to be used to ream prepare the humeral bone for accepting the implant. It has a spring loaded alignment pin on the proximal (reaming) end used in both alignment of the reamer and as an indication that the reamer has been seated fully.
Manufacturer
Encore Medical, Lp
1 Event
- Recall of RSP Humeral Socket Reamer (Size 32 SML)

Manufacturer

Encore Medical, Lp

Manufacturer Address
Encore Medical, Lp, 9800 Metric Blvd, Austin TX 78758
Source
USFDA

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