Recall Z-2876-2018 ยท LXH Orthopedic Manual Surgical Instrument
Zimmer Biomet, Inc.
Persona Partial Knee System Spacer Block Alignment Tower, Item No. 42-5399-006-35 Product Usage: Intended to aid in preparatory surgical procedures
| Date | Jun 22, 2018 |
| Status | Terminated |
| Reason | The PPK System Spacer Block Alignment Tower mating feature that mates with the spacer block was undersized, which could potentially lead to mating issues between the devices. This could cause a delay in surgery of less than 30 minutes. There is an option in the surgical technique for performing limb alignment without the alignment tower. |
| Root cause | Process control |
| Action | On June 22, 2018, the firm distributed Urgent Medical Device Recall letters to distributors and hospital risk managers. Actions for Risk Managers: 1. Review this notification and ensure that affected personnel are aware of the contents. 2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility. 3. Complete Attachment 1 Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.com. This form must be r |
| Quantity | 385 |
| Distribution | Worldwide Distribution - Nationwide distribution and the countries of Japan and Netherlands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.