Stapes prosthesis pistons carry an incorrect functional length on labeling
Titanium/fluoroplastic piston stapes prostheses are being recalled because the device labeling states an incorrect functional length. Seven units are affected.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall where a mislabeled implant dimension could lead to the wrong size being implanted, a risk of harm with no injuries reported.
Plain-English summary
The Titanium/Fluoroplastic Piston, 0.6 mm diameter x 3.75 mm length, model/catalog number 409-375, a stapes prosthesis, is being recalled. The action covers seven units, lot 122927.
The stated reason is an incorrect functional length on the device labeling. Surgeons select a stapes prosthesis by its functional length, so an incorrect stated length affects the choice of implant. The FDA classified the action as Class II.
Distribution was within the United States, in Maryland. The prostheses are supplied to healthcare facilities rather than sold to consumers.
Facilities should identify affected stock using the model number, UDI and lot number above, quarantine it, and follow the instructions issued by the manufacturer.
The recalled product
- Product
- TITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 3.75MM L Model/Catalog Number: 409-375 Product Description: Stapes Prosthesis
- Manufacturer
- Grace Medical, Inc.
- Affected units
- 7
Distribution
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