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U.S. Department of Health and Human Services

Class 2 Device Recall TITANIUM/FLUOROPLASTIC PISTON

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 Class 2 Device Recall TITANIUM/FLUOROPLASTIC PISTONsee related information
Date Initiated by FirmApril 03, 2026
Date PostedJune 04, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2308-2026
Recall Event ID 98773
510(K)NumberK060518 
Product Classification Prosthesis, partial ossicular replacement - Product Code ETB
ProductTITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 3.75MM L Model/Catalog Number: 409-375 Product Description: Stapes Prosthesis
Code Information Model/Catalog Number: 409-375 UDI code: (01)00844505000772(10)122927(17)310301 Lot Number: 122927
FEI Number 1000022662
Recalling Firm/
Manufacturer		 Grace Medical, Inc.
8500 Wolf Lake Dr Ste 110
Bartlett TN 38133-4104
For Additional Information Contact
901-380-7000
Manufacturer Reason
for Recall		Due to incorrect functional length on device labeling.
FDA Determined
Cause 2		Process control
ActionOn 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.
Quantity in Commerce7
DistributionU.S Nationwide distribution in the state of MD.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = ETB
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