FDA Medical Device Recalls (openFDA)
Encore Medical, Lp: AltiVate Reverse INSTRUMENTATION, HUMERAL SOCKET SHELL TRIAL, STANDARD, REF 804-06-152, Qty: 01, Encore Medical, LP Orthopedic surgical instrument. Product Usage: The humeral socket shell trial is used to replicate/trial the shell geometry of the AltiVate Reverse Standard Shell Humeral Stem implants. It assembles to the humeral broaches by a screw in order to replicate/trial the entire humeral stem implant geometry prior to implantation.
- Recall number
- Z-1241-2018
- Recalling firm
- Encore Medical, Lp
- Product
- AltiVate Reverse INSTRUMENTATION, HUMERAL SOCKET SHELL TRIAL, STANDARD, REF 804-06-152, Qty: 01, Encore Medical, LP Orthopedic surgical instrument. Product Usage: The humeral socket shell trial is used to replicate/trial the shell geometry of the AltiVate Reverse Standard Shell Humeral Stem implants. It assembles to the humeral broaches by a screw in order to replicate/trial the entire humeral stem implant geometry prior to implantation.
- Status
- Terminated
- Initiated
- 2018-01-30
- Posted
- 2018-03-05
- Terminated
- 2023-05-30
- Reason
- Broken or missing screws and retaining clips. This may be due to screw tolerance and material strength of the trial.
- Root cause
- Device Design
- Action
- The firm disseminated their field safety notices on 01/30/2018 by email. The letter identified the affected product, problem and actions to be taken. The notices requested the trails be returned for replacement.
- Quantity
- 387 units
- Distribution
- US Nationwide Distribution
- Lot, serial or model codes
- Lot Codes: 183312L03, 200006L01, 224643L01
- 510(k) numbers
- ["K141990"]
- PMA numbers
- not on file
- Product code
- PHX
- 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