Recall Z-2025-2025 · PHX Shoulder Prosthesis, Reverse Configuration
Limacorporate S.p.A
PRIMA 4MM ECCENTRICAL ADAPTOR WITH SCREW, REF:1367.15.704, Sterile
| Date | Jun 25, 2025 (initiated May 19, 2025) |
| Status | Open, Classified |
| Reason | There is the potential that the eccentrical adaptor with screw, black laser marking, use to identify the position may be missing. |
| Root cause | Process design |
| Action | On May 19, 2025, Enovis (Limacorporate S.p.A) issued a recall notification via e-mail. Enovis provided customers with an updated notification on May 28, 2025 to provide additional information. Enovis asked consignees to take the following steps: 1. Review your stock for the products and lot numbers for the items to be returned and quarantine immediately the affected devices. 2. This notice needs to be passed on to all those within your organization or to any organization where the product has been transferred. 3. If you have further distributed the product, please provide this recall noti |
| Quantity | 9 units |
| Distribution | Worldwide - US Nationwide distribution in the states of VA, FL, SC, MS, NY, TX and the countries of Italy, Poland, France. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K212800 | PRIMA Humeral System and SMR Glenosphere Ø42 Lima Corporate S.P.A., Feb 25, 2022 |