Recall record at a glance
| Official record | Z-2075-2015 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Musculoskeletal Transplant Foundation, Inc. |
| Report date | Jul 22, 2015 |
| Recall initiation date | May 27, 2015 |
| Quantity | 117 units |
| Location | Edison, NJ, United States |
Official product description
Allofix Insertion Kit, 2.0 mm, Single Drill, Product Usage: MTF Surgical Instruments are designed for the specific needs of the orthopedic surgeon and are intended to be used in conjunction with the associated allograft. This kit is for single use only.
Why the product was recalled
Musculoskeletal Transplant Foundation is recalling a certain lot of Allofix Insertion Kits because they are labeled as having a 2.0mm diameter drill however it may contain a 2.4 mm diameter drill.
Distribution information
US Nationwide Distribution in the states of AZ, CA, CO, FL, IL, MI, MN, NC, NJ, NV, PA, TN, TX, UT, WA and WV.
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: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit.
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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