Biomet Microfixation Temporomandibular Joint (TMJ) Patient Matched Left Fossa Part# CP751506 The Total Temporomandibular
FDA device recall Z-2566-2014 · posted 2014-09-02 · Terminated
Recall details
- Recalling firm
- Biomet Microfixation, LLC
- Reason for recall
- Product mix occurred prior to final package and labeling process.
- Action taken
- Biomet Microfixation, Inc. sent an Urgent Medical Device Field Notice dated September 20, 2013 to its customer. The customer was instructed to: 1) Immedicately quarantine the device. 2) Discontinue use and return to Biomet Microfixation. 3) If the product was further distributed, the letter must be forwarded to the firm's customers. 4) A replacement device will be shipped priority upon completion. Questions related to this notice should be directed to 904-741-9448 or 904-239-6671. For questions regarding this recall call 904-741-4400.
- Root cause
- Mixed-up of materials/components
- Status
- Terminated
- Product code
- LZD
- Quantity affected
- 1
- Distribution
- Worldwide Distribution to Denmark only.
- Date initiated
- 2013-09-20
- Date posted
- 2014-09-02
- Date terminated
- 2014-10-03
- Location
- Jacksonville, FL
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