Device recall

Z-2739-2011: Reverse Shoulder Prosthesis System RSP Humeral Socket Shell DJO 9800 Metric…

FDA device recall · Class II · Encore Medical, Lp

Key facts

Recall number (Z-number) Z-2739-2011
Recall event 58562
Product 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…
Product code KWS
Recalling firm Encore Medical, Lp
Recall class Class II
Status Terminated
Termination date Jan 25, 2012
510(k) numbers K051075
FEI number 1000116912

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 100–999 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

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