Recall Z-2127-2014 ยท HWC Screw, Fixation, Bone
Small Bone Innovations
Small Bone Innovations 3.0/4.0mm AutoFIX" Cannulated Compression Screw System Sets, Implants, and Instruments Indications for Use: AutoFIX" cannu lated screws are indicated for the treatment of fractures, non-unions, pseudoarthrosis and degenerative changes as well as corrective osteotom ies geared towards a functionally stable osteosynthesis in small bones.
| Date | Jul 30, 2014 (initiated May 19, 2014) |
| Status | Terminated |
| Reason | Small Bone Innovations (SBi) is recalling all lots of 3.0/4.0mm AutoFIX" Cannulated Compression Screw System Sets, Implants, and Instruments to update the IFU. |
| Root cause | Process control |
| Action | Small Bone Innovations sent an Urgent Medical Device Recall letter, dated May 19, 2014, to all affected customers. The letter that described the product problem, and the action to be taken by the customer. was sent to sales reps, stocking customers, and distributors. Customers were instructed that a copy of the IFU should be stored with each unpackaged AutoFIX 3.0/4.0mm Compression Screw Sets, Implants, or Instruments in their current inventory. Customers were instructed to return all packaged affected product which would be replaced by the firm with an updated IFU. A Federal Express ret |
| Quantity | 506 |
| Distribution | Nationwide Distribution including TN, OK, AZ, PA, TX, MO, NY, NC, CA, FL, WA, AL, IN, NH, SD, and OH. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052576 | SBI AUTOFIX Small Bone Innovations, LLC, Nov 7, 2005 |