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Terminated

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

FDA Recall Z-1382-2017 · Posted 2017-02-28

Recalling FirmMatrix Surgical Holdings, LLC
Recall StatusTerminated
Product CodeKKY
Date Initiated2017-01-25
Date Terminated2017-05-24
Product Quantity28

Reason for Recall

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

Firm 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.

Root Cause

Other

Distribution Pattern

Worldwide Distribution to the countries of : Brazil, Chile, Colombia, Norway, Saudi Arabia, South Africa, Sweden and Taiwan

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K123908OMNIPORE SURGICAL IMPLANTS AND ACCESSORIESMatrix Surgical USA · 2013-07-31

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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