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U.S. Department of Health and Human Services

Class 2 Device Recall RSP Humeral Socket Reamer (Size 32 SML)

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  Class 2 Device Recall RSP Humeral Socket Reamer (Size 32 SML) see related information
Date Initiated by Firm September 28, 2011
Date Posted November 02, 2011
Recall Status1 Terminated 3 on March 29, 2013
Recall Number Z-0150-2012
Recall Event ID 59991
Product Classification Orthopedic manual surgical instrument - Product Code LXH
Product 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.
Code Information All lots are being recalled.  DJO Surgical Part Number 804-02-013, 804-02-014, and 804-02-015
Recalling Firm/
Manufacturer		 Encore Medical, Lp
9800 Metric Blvd
Austin TX 78758
For Additional Information Contact Teffany Hutto
512-832-9500
Manufacturer 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.
FDA Determined
Cause 2		 Device Design
Action 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.
Quantity in Commerce 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 America, Italy, Saudi Arabia, United Kingdom, and Canada.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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