Recall Z-1008-2017 ยท JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Smith & Nephew, Inc.
REFLECTION(R) DEAD BLOW MALLET, REF 71362106, QTY: (1), NON-STERILE, Smith & Nephew, Inc,. Memphis, TN 38116
| Date | Nov 16, 2016 |
| Status | Terminated |
| Reason | The firm received complaints of cracks in the weld on the head of the mallet. In the reported cases, some of the lead beads and particles escaped from the mallet into the surgical wound. |
| Root cause | Process control |
| Action | Smith and Nephew sent an Urgent - Product Recall 1 st Notification dated November 16, 2016, to all affected customers. Actions for Hospital Representatives: 1. Please inspect your inventory and locate any unused devices from the above listed product and batch numbers, and quarantine them immediately. 2. Complete the last two columns in the Inventory Return Certification Form on the following page, indicating the quantities that need to be returned. If you do not have product to return, please place an x in the column No Product to Return. Include your contact information in the spaces provi |
| Quantity | 4444 units |
| Distribution | Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico and to the countries of : Argentina, Austria, Australia, Belgium, Bahrain, Brazil, Canada, China, Colombia, Costa Rica, Dubai, Denmark, Germany, Finland, France, Great Britain, Greece, Hong Kong, Ireland, Israel, India, It |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123598 | SMITH & NEPHEW, INC. HIP SYSTEM INSTRUMENTATION Smith & Nephew, Inc., Jun 28, 2013 |