Reverse Shoulder Prosthesis System RSP Humeral Socket Shell DJO 9800 Metric Blvd. Austin, TX 78758 STERILE R Model numbe
FDA device recall Z-2739-2011 · posted 2011-07-06 · Terminated
Recall details
- Recalling firm
- Encore Medical, Lp
- Reason for recall
- The device has the potential to not appropriately mate with the humeral stem.
- Action taken
- 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
- Status
- Terminated
- Product code
- KWS
- Quantity affected
- 81 units
- Distribution
- 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.
- Date initiated
- 2011-04-18
- Date posted
- 2011-07-06
- Date terminated
- 2012-01-25
- Location
- Austin, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ENCORE REVERSE SHOULDER PROSTHESIS (K051075) | Encore Medical L.P. | 2005-05-27 |