Acetabular Bearing Components Recalled for Marketing Without FDA Clearance
Synovo Production is recalling 1,681 acetabular bearing components that were marketed without FDA clearance.
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: This is a Class II medical device (orthopedic implant component) marketed without FDA 510(k) clearance. While no illnesses or injuries are reported in the source, this represents a risk-of-harm implanted device marketed without FDA review for safety and effectiveness.
Plain-English summary
Synovo Production is recalling 1,681 acetabular bearing components marketed under reference numbers 01-02-4254, 01-02-4456, 01-02-4558, 01-02-4760, 01-02-4962, 01-02-5164, and 01-02-5266. These are Class II medical devices used in hip implants, made of ultra-high-molecular-weight polyethylene (UHMWPE).
The components were marketed in the United States without FDA 510(k) clearance. FDA requires medical device manufacturers to obtain clearance before marketing Class II devices.
The recalled components were distributed nationwide in the United States, including distribution in Washington state. Patients and healthcare providers should contact Synovo Production or consult the FDA recall notice for additional product information.
The recalled product
- Product
- ACETABULAR BEARING (xx)MM I.D X (xx) O.D. UHMWPE 1020, STERILEEO, Reference Numbers: 01-02-4254 01-02-4456 01-02-4558 01-02-4760 01-02-4962 01-02-5164 01-02-5266
- Manufacturer
- Synovo Production
- Hazard
- no-fda-clearance
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: 00814193025906/01-02-4254
- 00814193025913/01-02-4456
- 00814193025920/01-02-4558
- 00814193025937/01-02-4760
- 00814193025968/01-02-4962
- 00814193025944/01-02-5164
- 00814193025951/01-02-5266
- REF Number/Lot Number: 01-02-4254 01024254FNN612
- 01-02-4254 01024254FNN613
- 01-02-4254 01024254GNN614
- 01-02-4254 01024254FNN620
- 01-02-4254 01024254GNN623
- 01-02-4254 01024254FNN644
- 01-02-4254 01024254NN651
- 01-02-4254 01024254NN652
- 01-02-4254 01024254NN741
- 01-02-4456 01024456ENN613
- 01-02-4456 01024456FNN614
- 01-02-4456 01024456ENN620
- 01-02-4456 01024456FNN620
Distribution
Distributed nationwide across the United States.
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