Reverse Shoulder Prosthesis System RSP Humeral Socket Shell DJO 9800 Metric Blvd. Austin, TX 78758 STERILE R Model numbers: 508-00-000 and 508-00-008. The Reverse Shoulder Prosthesis (RSP) is indicated for use in patients with a grossly rotator cuff deficient shoulder joint with severe arthropathy or a previously failed joint replacement with a gross rotator cuff deficient shoulder joint. The patient's joint must be anatomically and structurally suited to receive the selected implant (s), and a functional deltoid muscles in necessary to use the device.
FDA Recall Z-2739-2011 · Posted 2011-07-06
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Recalling FirmEncore Medical, Lp
Recall StatusTerminated
Product CodeKWS
Date Initiated2011-04-18
Date Terminated2012-01-25
Product Quantity81 units
Reason for Recall
The device has the potential to not appropriately mate with the humeral stem.
Firm Action
DJO Surgical sent an "URGENT FIELD SAFETY NOTICE" letter dated April 18, 2011 to all affected customers. The letter described the product, problem, and the actions to be taken by the customers.
The letter instructed customers to quarantine affected products and to contact Customer Service to obtain replacement products and a RMA.
Questions are directed to the Director of Commercial Logistics at 512-834-6330.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide Distribution--USA (nationwide) including the states of CA, FL, IL, LA, MA, MD, ME, NM, NY, OK, PA, SC, TN, TX, UT, and WA and the countries of Germany, Italy, and United Kingdom.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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