FDA Medical Device Recalls (openFDA)
TMJ Solutions Inc: Stryker TMJ Unilateral Implant, REF: GHG010, consisting of the following components: Ref: CHG010AM, Anatomical Bone Model, Accessory, REF: CHG010RF, Glenoid Fossa Component, Right, REF: CHG010RM, Mandibular Component, Right.
- Recall number
- Z-3264-2024
- Recalling firm
- TMJ Solutions Inc
- Product
- Stryker TMJ Unilateral Implant, REF: GHG010, consisting of the following components: Ref: CHG010AM, Anatomical Bone Model, Accessory, REF: CHG010RF, Glenoid Fossa Component, Right, REF: CHG010RM, Mandibular Component, Right.
- Status
- Open, Classified
- Initiated
- 2024-07-24
- Posted
- 2024-09-26
- Terminated
- not on file
- Reason
- Patient-fitted temporomandibular (TMJ) prothesis contained incorrect components, SterileEO
- Root cause
- Mixed-up of materials/components
- Action
- On May 29, 2024, TMJ Solutions Inc. spoke with consignees concerning the recall device.
- Quantity
- 1
- Distribution
- US Nationwide distribution in the state of MN.
- Lot, serial or model codes
- Order # 101432374 - Lot # 2403081022, UDI: (01)07613327627800/(01)07613327625551
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- 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