Recall Z-0043-2018 ยท HWC Screw, Fixation, Bone
MicroPort Orthopedics Inc.
MicroPort Orthopedics SCHANZ SCREW SELF DRILL, SIZE 4mm, REF 20070057, STERILE R Product Usage: MPO Total Hip Systems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio
| Date | Sep 18, 2017 |
| Status | Terminated |
| Reason | The item is being recalled due to an inadequate pouch seal. This defect has the potential to lead to a loss of sterile pouch integrity, which could impact the products sterility assurance and may lead to serious adverse events such as infections, both localized and systemic. |
| Root cause | Packaging process control |
| Action | Microport initiated their recall by letter sent via email on 09/18/2017. The letter identified the affected product, problem and actions to be taken. The consignees were directed to check their stock, including all kits and consignment stock to immediately determine if any affected product was in stock. The firm requested return of the recalled units. Consignees with questions regarding the return of the product were directed MPOs Customer Experience Department available Monday through Friday 7:30 am to 7:30 pm CST, at 1-866-872-0211. |
| Quantity | 48 units |
| Distribution | Worldwide Distribution - US Nationwide in the states of TX, AL, AZ CO, KS ,ME MO, WB, LA, CA, MD, including PR and the country of CANADA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K952296 | SYNTHES (USA) [SYNTHES[ SELF-DRILLING SCHANZ SCREW Synthes (Usa), Aug 18, 1995 |