Femoral Resurfacing Cup Components Marketed Without Required FDA Clearance
Synovo Production recalled 496 femoral resurfacing cup components that were marketed without FDA clearance. These hip implant components were distributed in the United States.
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: These are high-risk orthopedic implants marketed without FDA clearance, a significant regulatory violation. No injuries or adverse events have been reported. Per the rubric, risk-of-harm medical devices without reported injury receive a High (3) rating.
Plain-English summary
Synovo Production is recalling 496 femoral resurfacing cup components because they were marketed without FDA clearance. These orthopedic implants were sold and distributed in the United States. Femoral resurfacing cups are used in hip replacement surgery.
No injuries or illnesses have been reported. However, because these components were not cleared by the FDA, they should not have been marketed or sold. Patients who received these implants should consult with their healthcare provider.
Patients and healthcare providers can identify the recalled components using the Reference Numbers: 01-03-0042, 01-03-0044, 01-03-0045, 01-03-0047, 01-03-0049, 01-03-0051, and 01-03-0052. Specific lot numbers are available from the FDA's recall notice.
The recalled product
- Product
- Femoral Resurfacing Cup - (xx)MM, Ti-6AI-4V ELI, TiN CERAMIC W/ PLASMA SPRAY, STERILEEO, Reference Numbers: 01-03-0042 01-03-0044 01-03-0045 01-03-0047 01-03-0049 01-03-0051 01-03-0052
- Manufacturer
- Synovo Production
- Affected units
- 496
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 (20)
- UDI/REF Number: 00814193025708/01-03-0042
- 00814193025678/01-03-0044
- 00814193025692/01-03-0045
- 00814193025685/01-03-0047
- 00814193025654/01-03-0049
- 00814193025661/01-03-0051
- 00814193025753/01-03-0052
- REF Number/Lot Number: 01-03-0044 01030044K2NN656
- 01-03-0044 01030044K3NN736
- 01-03-0045 01030045LNN657
- 01-03-0045 01030045MNN670
- 01-03-0045 01030045N1NN694
- 01-03-0045 01030045NNN694
- 01-03-0045 01030045QNN733
- 01-03-0045 01030045RNN742
- 01-03-0047 01030047LNN657
- 01-03-0047 01030047L4NN662
- 01-03-0047 01030047MNN674
- 01-03-0047 01030047N1NN689
- 01-03-0047 01030047NNN689
Distribution
Part of a larger recall action
This product is one of 3 recalled by Synovo Production under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
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