Recall Z-2308-2026 ยท ETB Prosthesis, Partial Ossicular Replacement
Grace Medical, Inc.
TITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 3.75MM L Model/Catalog Number: 409-375 Product Description: Stapes Prosthesis
| Date | Jun 4, 2026 (initiated Apr 3, 2026) |
| Status | Open, Classified |
| Reason | Due to incorrect functional length on device labeling. |
| Root cause | Process control |
| Action | On 04/03/2026, the firm emailed a "RECALL NOTICE" to it single customer informing them that the firm determined the pistons were manufactured with an incorrect functional length. Devices are labeled as 3.75 mm but have an actual functional length of 4.00 mm. The customer was instructed to: " Immediately discontinue use and quarantine affected product " Return affected product using the provided RMA " If any devices have been used, provide the date(s) of surgery on the response form " Complete and return the enclosed Recall Response Form For questions - contact Grace Medical at 901-386-0990 |
| Quantity | 7 |
| Distribution | U.S Nationwide distribution in the state of MD. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060518 | PARTIAL OSSICULAR REPLACEMENT PROSTHESES Grace Medical, Inc., Jun 28, 2006 |