Biomet Microfixation Recalls TMJ Fossa Component Due to Product Mix-Up
Biomet Microfixation is recalling one unit of a TMJ fossa component because a product mix-up occurred before final packaging and labeling.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text explicitly states that the issue was a product mix-up prior to final packaging and labeling, with no reported illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Biomet Microfixation, LLC is recalling one unit of the Biomet Microfixation Temporomandibular Joint (TMJ) Patient Matched Left Fossa, Part #CP751506, Lot #478490. The recall was initiated because a product mix-up occurred prior to the final package and labeling process.
The affected product is a component of the Total Temporomandibular Joint (TMJ) replacement system, which is implanted in the jaw to reconstruct a diseased or damaged temporomandibular joint. The specific unit involved in this recall was distributed to Denmark only.
Consumers and healthcare providers who have this specific part number and lot number should contact Biomet Microfixation, LLC for further instructions. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- Biomet Microfixation Temporomandibular Joint (TMJ) Patient Matched Left Fossa Part# CP751506 The Total Temporomandibular Joint (TMJ) replacement system is implanted in the jaw to functionally reconstruct a diseased and/or damaged temporomandibular joint. The Total TMJ…
- Manufacturer
- Biomet Microfixation, LLC
- Affected units
- 1
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Part #CP751506 Lot #478490
Distribution
Distribution scope not specified by the agency.
Related recalls
Same manufacturer · Biomet Microfixation, LLC
See all →- ModerateBiomet Microfixation Recalls Surgical Trays Due to Part Number Mismatch
FDA (Devices) · 2017-05-24
- HighBiomet Microfixation Recalls Hard Tissue Replacement Implants Due to Sterility Deficiency
FDA (Devices) · 2016-09-14
- ModerateBiomet Thinflap System Cases Recalled Due to Lid Opening Difficulty
FDA (Devices) · 2015-10-28
- ModerateBiomet Neuro Combo Set Case Lid Requiring Excessive Force Recalled
FDA (Devices) · 2015-10-28
- ModerateBiomet Microfixation Recalls Total Temporomandibular Joint Replacement Systems
FDA (Devices) · 2014-12-17
Same hazard · mis labeling
See all →- SevereImperio Distribution Recalls Beef Jerky Produced Without Federal Inspection
USDA FSIS · 2026-10-24
- HighJ K Patisserie Chocolate Chip Cookies Recalled for Undeclared Soy
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- LowMindray ePM Series Patient Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
Similar recalls
- ModerateBiomet Microfixation Recalls Total Temporomandibular Joint Replacement System
FDA (Devices) · 2014-12-17
- ModerateBiomet Microfixation Recalls Total Temporomandibular Joint Replacement Systems
FDA (Devices) · 2014-12-17
- ModerateTMJ Solutions Recalls Misidentified Right Mandibular Component
FDA (Devices) · 2018-04-25
- HighStryker TMJ Unilateral Implant Recalled Due to Incorrect Components
FDA (Devices) · 2024-10-02
- CriticalJaw joint implants recalled over a discrepancy in screw hole position
FDA (Devices) · 2025-11-26
- HighTMJ Bilateral Implants with Incorrect Patient-Specific Components Recalled
FDA (Devices) · 2026-07-01