TITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 3.75MM L Model/Catalog Number: 409-375 Product Description: Stapes Prosthesis
FDA device recall Z-2308-2026 · posted 2026-06-04 · Open, Classified
Recall details
- Recalling firm
- Grace Medical, Inc.
- Reason for recall
- Due to incorrect functional length on device labeling.
- Action taken
- 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 or Thomas.fearnley@gracemedical.com.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- ETB
- Quantity affected
- 7
- Distribution
- U.S Nationwide distribution in the state of MD.
- Date initiated
- 2026-04-03
- Date posted
- 2026-06-04
- Location
- Bartlett, TN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PARTIAL OSSICULAR REPLACEMENT PROSTHESES (K060518) | Grace Medical, Inc. | 2006-06-28 |