Acetabular Fixation Cups Recalled for Marketing Without FDA Clearance
Synovo Production is recalling 764 acetabular fixation cups marketed without FDA clearance or approval. These hip replacement components were distributed nationwide in Washington state.
What this means for you
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: Class II medical devices marketed without FDA clearance create a risk of potential harm. Although no adverse events have been reported, the regulatory violation of an unapproved moderate-risk device justifies a High severity rating per the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Synovo Production is recalling 764 acetabular fixation cup units used in hip replacement surgery. These medical devices are titanium-based hip implant components with ceramic coating and plasma spray surface.
The devices were marketed and distributed without FDA clearance or approval. The FDA classified this as a Class II recall, indicating a moderate-risk medical device marketed without proper regulatory authorization. No adverse events or patient injuries have been reported.
The affected devices were distributed nationwide in Washington state. Healthcare facilities and patients who received these components should contact Synovo Production or their healthcare provider for additional information. Patients with concerns about their implant should consult their surgeon.
The recalled product
- Product
- ACETABULAR FIXATION CUP, (xx)MM, 5 HOLE, Ti-6AI-4V ELI TiN CERAMIC W/PLASMA SPRAY, STERILEEO, Reference Numbers: 01-01-0554 01-01-0556 01-01-0558 01-01-0560 01-01-0562 01-01-0564 01-01-0566
- Manufacturer
- Synovo Production
- Hazard
- uncleared-device
- regulatory-violation
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:00814193025807/01-01-0554
- 00814193025814/01-01-0556
- 00814193025821/01-01-0558
- 00814193025838/01-01-0560
- 00814193025845/01-01-0562
- 00814193025852/01-01-0564
- 00814193025869/01-01-0566
- REF Number/Lot Number: 01-01-0562 01010562H1NN732
- 01-01-0562 01010562HNN733
- 01-01-0562 01010562J1NN745
- 01-01-0564 01010564CNN656
- 01-01-0564 01010564C3NN658
- 01-01-0564 01010564CNN659
- 01-01-0564 01010564DNN671
- 01-01-0564 01010564D1NN681
- 01-01-0564 01010564ENN697
- 01-01-0564 01010564E2NN698
- 01-01-0564 01010564FNN733
- 01-01-0564 01010564G1NN744
- 01-01-0564 01010564GNN746
Distribution
Distributed nationwide across the United States.
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