Recall Z-2598-2023 ยท LZN Cement Obturator
Stryker Corporation
Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle-Allows the user to mix bone cement witha constant high vacuum through the process Catalog Number: 0306-563-000
| Date | Sep 19, 2023 (initiated Aug 7, 2023) |
| Status | Open, Classified |
| Reason | Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, to disassemble or break off during use, can lead to the potential for loss of function of the ACM system and bio-incompatibility due to components falling into surgical site |
| Root cause | Under Investigation by firm |
| Action | Stryker issued Urgent Medical Device Recall letter on 8/07/23. Letter states reason for recall, health risk and action to take: Actions needed 1. Immediately review your inventory to locate and quarantine any affected products at your facility. 2. Return the enclosed Business Reply Form (BRF), even if affected product is no longer in inventory, to the email Instruments.Recalls@stryker.com. 3. Upon receipt of the completed BRF, Stryker will provide a shipping label to return recalled product on-hand. 4. A replacement order will be shipped to customers upon receipt of the recalled product. 5. Ma |
| Quantity | 5155 units US; 1607 units OUS |
| Distribution | Nationwide Foreign: Austria Belgium Canada France Germany Hong Kong Italy Malaysia Poland Singapore South Korea Spain Taiwan Thailand UK |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K931847 | BIO-PREP CEMENT RESTRICTOR Biomedical Devices, Inc., Jun 28, 1994 |