FDA Medical Device Recalls (openFDA)
TMJ Solutions Inc: TMJ Bilateral Implants, REF: CHG020
- Recall number
- Z-2524-2026
- Recalling firm
- TMJ Solutions Inc
- Product
- TMJ Bilateral Implants, REF: CHG020
- Status
- Open, Classified
- Initiated
- 2026-02-11
- Posted
- 2026-06-22
- Terminated
- not on file
- Reason
- Custom temporomandibular joint implant may have contained incorrect patient-specific components that led to a poor fit of the implant, leading to a right-sided open bite.
- Root cause
- Process control
- Action
- On 2/11/2026, the customer was contacted and verbally informed of the recall. On 4/23/2026, a recall notice was sent to the customer asking them to take the following action: 1) Inform all appropriate members of your organization who need to be made aware of this action. 2) The affected product is already implanted. Following explantation, during revision surgery, the explanted device shall be returned to the firm's sales representative. 3) Complete and return the Business Reply Form (BRF) via email to cmf-pfa@stryker.com Please contact the firm's quality department cmf-pfa@stryker.com with questions or concerns.
- Quantity
- 1
- Distribution
- US Nationwide distribution in the state of MA.
- Lot, serial or model codes
- UDI-DI: 07613327626575, Lot: 2508181038
- 510(k) numbers
- not on file
- PMA numbers
- ["P980052"]
- Product code
- LZD
- Firm FEI
- 3001237463
- Firm city
- Ventura
- Firm state
- CA
- 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