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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Biomet Microfixation, LLC: Laser etching on the parts is wider and deeper than the conditions previously validated.

Agency Publication Date: December 16, 2014
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Affected Products

Product: Total Temporomandibular Joint Replacement System- 45mm Lft Narrow Ti Mand

Model 01-6546TI, Lot #s: 531880B, 535890B, 531870A, 531870B, 531880A, 535890D, 535890A, 535890C.

Product: Total Temporomandibular Joint Replacement System- 45mm Lft Stand Off Ti Mand Reconstruction of the temporomandibular joint

Models 24-6646TI, Lot #s: 526000A, 526000B, 526010B, 526010A, 535390A, 535390B, 535390C, 535390D, 538720A, 538720B, 538720C, 538720D

Product: Total Temporomandibular Joint Replacement System- 45mm Rt Narrow Ti Mand Reconstruction of the temporomandibular joint

Model 01-6545TI, Lot #s: 535380D, 531850A, 531850B, 531860A, 531860B, 535380B, 535380C, 535380A.

Product: Total Temporomandibular Joint Replacement System- 45mm Rt Stand Off TI Mand Reconstruction of the temporomandibular joint

Model 24-6645TI, Lot #s: 472580A, 472590B, 472580B, 472590A, 526030A, 526020A, 526020B, 526030B,

Product: Total Temporomandibular Joint Replacement System- 50mm Lft Narrow Ti Mand Reconstruction of the temporomandibular joint

Model 01-6551TI, Lot #s: 535370A, 535370B, 535370C, 535370D.

Product: Total Temporomandibular Joint Replacement System- 50mm Lft Stand Off Ti Mand Reconstruction of the temporomandibular joint

Model 24-6651TI, Lot #s: 472560A, 472560B, 472570A, 518520A, 518520B, 472570B.

Product: Total Temporomandibular Joint Replacement System- 50mm Rt Narrow Ti Mand Reconstruction of the temporomandibular joint

Model 01-6550TI, Lot #s: 531890A, 531890B, 531900A, 531900B, 544220B, 544230A, 544230B, 544200A, 544200B, 544210A, 544210B, 544220A.

Product: Total Temporomandibular Joint Replacement System- 50mm Rt Stand Off Ti Mand Reconstruction of the temporomandibular joint

Model 24-6650TI, Lot #s: 531960A, 531960B.

Product: Total Temporomandibular Joint Replacement System- 50mm Rt Standard Ti Mand Reconstruction of the temporomandibular joint

Model 24-6650TI, Lot #s: 518480B, 518480A, 525970A, 525970B, 525980B, 518490A, 526070A, 525990A, 525990B, 526060A, 526060B, 526070B, 525980A, 550330A, 550330B, 550340A, 550340B, 550350A, 550360A, 550360B, 518490B, 525960A, 525960B,

Product: Total Temporomandibular Joint Replacement System- 50mm Lft Standard Ti Mandi Reconstruction of the temporomandibular joint

Model 24-6551TI, Lot #s: 544160A, 525190A, 525190B, 525180B, 544170A, 544180B, 544160B, 525180A, 544180A.

Product: Total Temporomandibular Joint Replacement System- 55mm Lft Standard Ti Mand Reconstruction of the temporomandibular joint

Model 24-6556TI, Lot #s: 520240A, 520230A, 550400A, 550390B, 520230B, 520240B, 535400B, 550400B, 535400A, 535410A, 535410B, 550370A, 550370B, 550380A, 550380B, 550390A.

Product: Total Temporomandibular Joint Replacement System- 55mm Rt Standard Ti Mand Reconstruction of the temporomandibular joint

Model 24-6555TI, Lot #s: 525210B, 525200A, 525200B, 525210A.

Product: Total Temporomandibular Joint Replacement System- 45mm Lft Standard Ti Mand Reconstruction of the temporomandibular joint

Model 24-6546TI, Lot #s: 526040B, 526050A, 526040A, 526050B.

Product: Total Temporomandibular Joint Replacement System- 45mm Rt Standard TI Mand Reconstruction of the temporomandibular joint

Model 24-6545TI, Lot #s: 520220B, 520220A, 520210A, 520210B

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 69644
Status: Resolved
Manufacturer: Biomet Microfixation, LLC
Manufactured In: United States
Units Affected: 14 products (42)

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.