Acetabular Bearing Components Recalled for Marketing Without FDA Clearance
Synovo Production is recalling 1,681 acetabular bearing components that were marketed without FDA clearance.
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 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
- Affected units
- 1,681
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
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
Same manufacturer · Synovo Production
See all →- HighAcetabular Fixation Cups Recalled for Marketing Without FDA Clearance
FDA (Devices) · 2024-04-17
- HighFemoral Resurfacing Cup Components Marketed Without Required FDA Clearance
FDA (Devices) · 2024-04-17
Other medical device recalls
- SevereEthicon Recalls Nylon Sutures With Distorted Needles
FDA (Devices) · 2026-11-04
- ModerateCanon Alphenix Interventional Angiography System Recalled for Software Error
FDA (Devices) · 2026-11-04
- HighPhilips Model 712010 Medical Device Recalled for Potential Immediate Failure
FDA (Devices) · 2026-11-04
- ModeratePhilips Azurion 7 B20 Recalled for Unspecified Solid-State Drive Reliability Issues
FDA (Devices) · 2026-11-04
- SevereMedtronic OmniaSecure Model 3930M Ventricular Lead Recall for Fixation Issues
FDA (Devices) · 2026-11-04
Similar recalls
- HighAcetabular liners recalled over packages containing the wrong component
FDA (Devices) · 2026-02-11
- ModerateSmith & Nephew Recalls R3 XLPE Acetabular Liners Due to Mislabeling
FDA (Devices) · 2013-08-14
- SevereMedtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss
FDA (Devices) · 2019-10-09
- ModerateSmith & Nephew Recalls Birmingham Hip Resurfacing Acetabular Cups for Labeling Defects
FDA (Devices) · 2018-06-27
- HighEMPOWR dual mobility poly bearings were packaged with the wrong implant
FDA (Devices) · 2025-07-30
- HighEMPOWR dual mobility OD42 bearings were packaged with the wrong implant
FDA (Devices) · 2025-07-30