Recall Z-0696-2020 ยท GFJ Mallet, Surgical, General & Plastic Surgery
Smith & Nephew, Inc.
smith&nephew PROFIX Mallet, 750 GRAMS, REF 71512452 - Product Usage: The PROFIX Mallet is a reusable surgical instrument used to tap instruments or implants during knee or hip surgery.
| Date | Nov 11, 2019 |
| Status | Terminated |
| Reason | There is a a potential failure mode associated with the use of the mallet, wherein the poly tip of the mallet may become loose and/or come off during use. If the potential failure mode occurs, particles generated in the poly thread potentially could enter the surgical field or a delay in surgery could occur if the tip disengages during the use of the mallet. |
| Root cause | Device Design |
| Action | The firm disseminated a medical device field correction notice on 11/11/2019 by letter. The letter explained the failure and requested the following actions be taken by hospital representatives: 1. Please check your inventory and complete the attached Inventory Correction Certification Form. 2. If you have the PROFIX 750 Gram Mallet, please maintain awareness of this notice. 3. When preparing for cleaning, disassemble the poly tip from the mallet and inspect disassembled components for damage or wear. 4. After cleaning, inspect disassembled components and ensure the components can be re-assem |
| Quantity | 1371 devices |
| Distribution | Worldwide distribution - US Nationwide distribution and countries of Belgium, Canada, China, Columbia, Costa Rica, Finland, France, Germany, Great Britain, Hong Kong, Italy, Netherlands, Norway, Panama, Poland, Switzerland, United Arab Emirates, Venezuela. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.