AltiVate Humeral Socket Shell Trial, Part Number 804-06-052 The glenoid baseplate is intended for cementless application
FDA device recall Z-0131-2016 · posted 2015-10-16 · Terminated
Recall details
- Recalling firm
- Encore Medical, Lp
- Reason for recall
- Difficulty assembling the shell trial to the broach and the retaining ring disassembled from the screw.
- Action taken
- The firm, DJO Global, sent an "URGENT FIELD SAFETY NOTICE" letter dated 9/16/15 to affected consignees/customers. The letter described the product, problem, and actions to be taken. The consignees/customers were instructed quarantine the device, pass the notice on to all who need to be aware within your organization, contact customer service to place a replacement order and receive an RMA number; and to complete a response form and return the recalled device for a replacement. If you have any questions, please call (512) 834-6302 or by email at desiree.hubby@djoglobal.com.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- PHX
- Quantity affected
- 20 units
- Distribution
- US Distribution to states of: PA, FL, ID, and CA.
- Date initiated
- 2015-09-15
- Date posted
- 2015-10-16
- Date terminated
- 2017-01-10
- Location
- Austin, TX
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ENCORE HUMERAL SHOULDER STEM (K141990) | Encore Medical L.P. | 2014-11-07 |