openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
device · product 1 of 3
Black Mamba Suture Passer. The Biomet Sports Medicine Mamba instruments are utilized to aid in passing suture through soft tissue. The Mamba Needle is designed for use with the Mamba Suture Passer. The needles are sterile, disposable, and for single-patient use only.
An investigation identified that high level friction may exist between the needle and Mamba suture passer instrument, causing the needle to break during use.
These labels are deterministic app interpretations, not FDA categories.
An investigation identified that high level friction may exist between the needle and Mamba suture passer instrument, causing the needle to break during use.
Code information
Catalog Number: 110010849 Lot Number: 169620, 253190
Distribution pattern
Nationwide Distribution-including the states of FL, NY, TX, VA, NV, MI, CA, IN, SD, GA, KY, NC, and AR.
device · product 2 of 3
Green Mamba Suture Passer. The Biomet Sports Medicine Mamba instruments are utilized to aid in passing suture through soft tissue. The Mamba Needle is designed for use with the Mamba Suture Passer. The needles are sterile, disposable, and for single-patient use only.
An investigation identified that high level friction may exist between the needle and Mamba suture passer instrument, causing the needle to break during use.
These labels are deterministic app interpretations, not FDA categories.
An investigation identified that high level friction may exist between the needle and Mamba suture passer instrument, causing the needle to break during use.
Code information
Catalog Number: 110010850 Lot Number: 231120, 253210
Distribution pattern
Nationwide Distribution-including the states of FL, NY, TX, VA, NV, MI, CA, IN, SD, GA, KY, NC, and AR.
device · product 3 of 3
Mamba Disposable Nitinol Needle. The Biomet Sports Medicine Mamba instruments are utilized to aid in passing suture through soft tissue. The Mamba Needle is designed for use with the Mamba Suture Passer. The needles are sterile, disposable, and for single-patient use only.
An investigation identified that high level friction may exist between the needle and Mamba suture passer instrument, causing the needle to break during use.
These labels are deterministic app interpretations, not FDA categories.
An investigation identified that high level friction may exist between the needle and Mamba suture passer instrument, causing the needle to break during use.
Code information
Catalog Number: 110010851 Lot Number: 139800, 139810, 139820
Distribution pattern
Nationwide Distribution-including the states of FL, NY, TX, VA, NV, MI, CA, IN, SD, GA, KY, NC, and AR.
