FDA Medical Device Recalls (openFDA)
Encore Medical, LP: AltiVate Reverse Small Socket Insert, 44mm Semi Constrained - E-Plus, Part Number: 509-03-044 - Product Usage: Per IFU, DJO Surgical shoulder devices are intended for treatment of patients who are candidates for shoulder arthroplasty per the Indication for use.
- Recall number
- Z-0117-2021
- Recalling firm
- Encore Medical, LP
- Product
- AltiVate Reverse Small Socket Insert, 44mm Semi Constrained - E-Plus, Part Number: 509-03-044 - Product Usage: Per IFU, DJO Surgical shoulder devices are intended for treatment of patients who are candidates for shoulder arthroplasty per the Indication for use.
- Status
- Terminated
- Initiated
- 2020-08-31
- Posted
- not on file
- Terminated
- 2024-04-19
- Reason
- Product mislabeled. Use may result in a delay in surgery, stopping of surgery, and revision surgery.
- Root cause
- Labeling False and Misleading
- Action
- On 08/31/2020, the firm notified affected customers via email using a letter titled, "URGENT FIELD SAFETY NOTICE", indicating the following: The firm requires that you do the following actions by September 11, 2020: 1. This notice needs to be passed on to all those within your organization or to any organization where the potentially affected product has been transferred. 2. Review your 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. You will be provided with a shipping label to return the affected product. 4. Return all affected devices quantities using the RMA number. Your actions above will demonstrate that you have received and understand this notification. If you have any questions, please contact the company's Regulatory Affairs Manager via email. Company telephone number is 1-800-321-9549.
- Quantity
- 15
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- Lot Number: 964W1000
- 510(k) numbers
- ["K172351"]
- PMA numbers
- not on file
- Product code
- KWS
- 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