FDA Medical Device Recalls (openFDA)
Encore Medical, LP: DJO EMPOWR KNEE Femoral Sizer
- Recall number
- Z-1524-2021
- Recalling firm
- Encore Medical, LP
- Product
- DJO EMPOWR KNEE Femoral Sizer
- Status
- Open, Classified
- Initiated
- 2021-02-05
- Posted
- not on file
- Terminated
- not on file
- Reason
- Incorrect assembly of a subcomponent by a vendor and as a result, the windows provided to show the size are facing the opposite direction.
- Root cause
- Nonconforming Material/Component
- Action
- On 02/05/2021, the firm sent an "URGENT FIELD SAFETY NOTICE" Recall letter to customers via e-mail informing them that a product complaint was received where a subcomponent of the sizer was assembled incorrectly. As a result, the windows provided to show the size are facing the opposite direction. When the sizer is in place, the size read from the distal facing side of the instrument is obscured. The risks associated with this issue include: -Delay in surgery -Revision surgery Customers are instructed to the below actions by February 26, 2021: 1. This notice needs to be passed on to all those within their organization or to any organization where the potentially affected product has been transferred. 2. Review their stock for the affected products and lot numbers and to quarantine the items until returned. 3. Contact Customer Service at 1-800-456-8696 to place a replacement order and receive an RMA number. Customers will be provided with a shipping label to return the affected product. 4. Return all affected devices (quantities listed above) using the RMA number. Any questions or assistance - contact the Manager, Regulatory Affairs at e-mail teffany.hutto@djoglobal.com
- Quantity
- 16 units
- Distribution
- U.S.: FL, IN, and MN O.U.S.: None
- Lot, serial or model codes
- Model Number: 800-05-034 Lot Number: 326336L02
- 510(k) numbers
- K143242
- PMA numbers
- not on file
- Product code
- JWH
- Firm FEI
- 1000116912
- Firm city
- Austin
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28