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OmniPore Surgical Implant recallZ-1382-2017 · Matrix Surgical Holdings, LLC · initiated Jan 25, 2017

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Matrix Surgical Holdings, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Mislabeling. The packaging labeled as left mandible contained a right mandible.

FDA root cause category: Other

What the company is doing

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.

Recall details

Recall number
Z-1382-2017
Status
Terminated
Initiated by the company
Jan 25, 2017
Posted by the FDA
Feb 28, 2017
Recalling firm
Matrix Surgical Holdings, LLC
Quantity
28
Product code
KKY
FDA submissions
K123908, K133046
Distribution
Worldwide Distribution to the countries of : Brazil, Chile, Colombia, Norway, Saudi Arabia, South Africa, Sweden and Taiwan

Product description

OP7543 Design Y Mandible Onlay - Medium - Left and OP7544 Design Y Mandible Onlay - Medium - Right

Code information (models, lots, serial numbers)

OP7543 (lot 00855421005666 01211086) and OP7544 (lot 00855421005673 013110816)

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

9 devices cleared under K123908, K133046 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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