CLASS II ONGOING Device recall · Reported 17 Apr 2024 · FDA Enforcement Report

Acetabular Fixation Cup, (xx)MM, 5 Hole recalled by Synovo Production

Synovo Production is recalling Acetabular Fixation Cup, (xx)MM, 5 Hole, Ti-6AI-4V Eli TiN Ceramic W/Plasma Spray, distributed nationwide in the US. The recall was initiated on 30 May 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI/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, 01-01-0566 01010566CNN663, 01-01-0566 01010566BNN670, 01-01-0566 01010566BNN671, 01-01-0566 01010566BNN688, 01-01-0566 01010566BNN689, 01-01-0566 01010566DNN699, 01-01-0566 01010556E1NN726, 01-01-0566 01010556E1NN727,

Quantity recalled764 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1496-2024
FDA event ID: 94278
Recalling firm: Synovo Production, Fullerton, CA
Classification: Class II
Status: Ongoing
Recall initiated: 30 May 2023
FDA classified: 8 Apr 2024
Reported: 17 Apr 2024
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Other Reasons
Device type: Hip & Knee Implants

Timeline

30 May 2023	Recall initiated by company
8 Apr 2024	Classified by FDA	+314 days
17 Apr 2024	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Medical device components were marketed without FDA clearance and without FDA approval

Product as listed by the FDA

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

Where it was distributed

US Nationwide distribution in the state of WA.

Nationwide Washington

Questions about this recall

Why was it recalled?

Medical device components were marketed without FDA clearance and without FDA approval

Which lots are affected?

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, 01-01-0566 01010566CNN663, 01-01-0566 01010566BNN670, 01-01-0566 01010566BNN671, 01-01-0566 01010566BNN688, 01-01-0566 01010566BNN689, 01-01-0566 01010566DNN699, 01-01-0566 01010556E1NN726, 01-01-0566 01010556E1NN727,

Where was it sold?

US Nationwide distribution in the state of WA.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 94278

This product is part of a recall event; the main page for the event is Femoral Resurfacing Cup - (xx)MM, Ti-6AI-4V Eli recalled.

Reported	Class	Recall	Company	Reason	Where
17 Apr 2024	CLASS II	Femoral Resurfacing Cup - (xx)MM, Ti-6AI-4V Eli recalled	Synovo Production	Other	Nationwide
17 Apr 2024	CLASS II	Acetabular Bearing (xx)MM I.D X (xx) O.D recalled by Synovo Production	Synovo Production	Other	Nationwide

More recalls from Synovo Production

All 3

Reported	Class	Recall	Company	Reason	Where
17 Apr 2024Device	CLASS II	Acetabular Bearing (xx)MM I.D X (xx) O.D recalled by Synovo Production	Synovo Production	Other	Nationwide
17 Apr 2024Device	CLASS II	Femoral Resurfacing Cup - (xx)MM, Ti-6AI-4V Eli recalled	Synovo Production	Other	Nationwide

Other Hip & Knee Implants recalls

All 3,097

Reported	Class	Recall	Company	Reason	Where
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled	Medline Industries	Other	Nationwide
26 Aug 2026Device	CLASS II	Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation	Kico Knee Innovation	Device Malfunction	19 states
26 Aug 2026Device	CLASS II	Veritas Standard Reverse Total Shoulder Veritas Standard recalled	restor3d	Device Malfunction	Nationwide
19 Aug 2026Device	CLASS II	Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled	Waldemar Link GmbH & Co. KG (Mfg Site)	Other	IN
12 Aug 2026Device	CLASS II	U2 Total Knee System Femoral offset bushing recalled	United Orthopedic	Device Malfunction	Nationwide