Recall Z-0399-2019 ยท KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Zimmer Biomet, Inc.
StageOne Hip, Models 431207 & 431209Usage: Product Usage: The single-use cement spacer molds are sterile disposables made of medical grade silicone with a 316L stainless steel reinforcement stem. They are designed to be filled with polymethylmethacrylate/gentamicin bone cement, or equivalent, by injecting with a dispenser/gun into the mold. After the cement cures, the temporary spacers are to b
| Date | Sep 21, 2018 |
| Status | Terminated |
| Reason | There is a potential for comingling of the 43MM and 51 MM molds |
| Root cause | Error in labeling |
| Action | On September 21, 2018, Zimmer Biomet issued URGENT MEDICAL DEVICE RECALL notices and Return Certification Forms to customers via courier service. Distributors are encouraged to take the following actions: Review this notification and ensure that affected team members are aware of the contents. 2. Immediately locate and quarantine affected product in your inventory. 3. Immediately return all affected product from your distributorship and from affected hospitals within your territory. a. Complete the Return Certification Form and send to CorporateQuality.PostMarket@zimmerbiomet.com within th |
| Quantity | 72 units |
| Distribution | US Nationwide Distribution in the states of: AZ, FL, MI, OH, VA & WI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052990 | STAGEONE DISPOSABLE CEMENT SPACER MOLD FOR TEMPORARY HIP PROSTHESIS WITH REINFORCEMENT STEM Biomet, Inc., Dec 16, 2005 |