Recall record at a glance
| Official record | Z-0057-2015 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Biomet, Inc. |
| Report date | Oct 15, 2014 |
| Recall initiation date | Sep 26, 2014 |
| Quantity | 12 units |
| Location | Warsaw, IN, United States |
Official product description
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.
Why the product was recalled
An investigation identified that high level friction may exist between the needle and Mamba suture passer instrument, causing the needle to break during use.
Distribution information
Nationwide Distribution-including the states of FL, NY, TX, VA, NV, MI, CA, IN, SD, GA, KY, NC, and AR.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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