Hip Cup Removal Instrument Recalled Due to Wrong Blade Assembly
Innomed is recalling the Cup Removal Starter Instrument due to a manufacturing error where the finisher blade was affixed instead of the starter blade. The wrong blade could compromise surgical performance during hip replacement procedures.
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: This is an FDA Class II recall for a surgical instrument with a manufacturing defect that affects device function. No injuries or illnesses have been reported, making the hazard theoretical; therefore the score does not exceed 3. However, the use of the wrong blade component during hip replacement surgery presents a significant risk-of-harm product, justifying a High severity rating.
Plain-English summary
Innomed, Inc. is recalling the Cup Removal Starter Instrument, model 54 MM (UDI/DI 00840277104007, Lot 1223K), due to a manufacturing defect identified in 41 devices.
During manufacturing, the 54 MM finisher blade was inadvertently affixed to the shaft of the CupX handle in place of the 54 MM starter blade. This assembly error means affected instruments contain the wrong blade type for their intended use.
The instruments were distributed to facilities in Florida, Georgia, Pennsylvania, New York, California, Virginia, South Dakota, Minnesota, Texas, Utah, North Carolina, and internationally to the United Kingdom, Denmark, Germany, Switzerland, Ireland, and Canada.
Healthcare providers who have received affected units should stop using them and contact Innomed directly. Hospitals should identify and quarantine inventory from Lot 1223K. Patients who have undergone hip replacement surgery with these instruments should consult their surgeon if they experience any complications related to the procedure.
The recalled product
- Product
- INNOMED CUP REMOVAL STARTER INSTRUMENT, REF 520054, Hip cutter blade cup
- Manufacturer
- Innomed, Inc.
- Hazard
- Affected units
- 41
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI/DI 00840277104007
- Lot Number 1223K
Distribution
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