FDA Medical Device Recalls (openFDA)
Matrix Surgical Holdings, LLC: OP7543 Design Y Mandible Onlay - Medium - Left and OP7544 Design Y Mandible Onlay - Medium - Right
- Recall number
- Z-1382-2017
- Recalling firm
- Matrix Surgical Holdings, LLC
- Product
- OP7543 Design Y Mandible Onlay - Medium - Left and OP7544 Design Y Mandible Onlay - Medium - Right
- Status
- Terminated
- Initiated
- 2017-01-25
- Posted
- 2017-02-28
- Terminated
- 2017-05-24
- Reason
- Mislabeling. The packaging labeled as left mandible contained a right mandible.
- Root cause
- Other
- Action
- Matrix Surgical sent an Urgent Product Recall e-mail dated January 26, 2017, to the foreign consignees. The distributors were instructed to return the product in inventory, and to conduct a sub-recall, if needed. For further questions, please call ( 404) 862-3794.
- Quantity
- 28
- Distribution
- Worldwide Distribution to the countries of : Brazil, Chile, Colombia, Norway, Saudi Arabia, South Africa, Sweden and Taiwan
- Lot, serial or model codes
- OP7543 (lot 00855421005666 01211086) and OP7544 (lot 00855421005673 013110816)
- 510(k) numbers
- ["K123908","K133046"]
- PMA numbers
- not on file
- Product code
- KKY
- Firm FEI
- 3009383407
- Firm city
- Atlanta
- Firm state
- GA
- 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