CLASS II ONGOING Device recall · Reported 9 Jul 2025 · FDA Enforcement Report

Apex Knee System recalled by Corin Medical

Corin Medical is recalling Apex Knee System, distributed nationwide in the US. The recall was initiated on 23 May 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel Number (Serial Numbers): KC-50090(580854, 582278), KC-50097(528456, 528457), KC-50110(531527, 532301, 586311), KC-50117(552924), KC-50130(528458, 548885, 548886, 548887, 548888, 573259), KC-50135(529093), KC-50137(527387, 528459, 555044, 568751), KC-50150(529072, 529094, 565748, 584973, 584974), KC-50155(586369), KC-50157(528460, 528461, 545943, 565831, 565832, 567009, 572398, 587261, 587262), KC-50170(528462, 529076, 550671, 585011), KC-50175(552532), KC-50177(529073, 588382), KC-50190(529074), KC-50197(548468, 548469, 548470), KC-52104(584975), KC-52554(589609), KC-52574(586115, 586117), KC-52774(584976), KC-55223(580117), KC-55243(580855).

Quantity recalled341 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-2069-2025
FDA event ID: 97006
Recalling firm: Corin Medical, Cirencester
Classification: Class II
Status: Ongoing
Recall initiated: 23 May 2025
FDA classified: 2 Jul 2025
Reported: 9 Jul 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Hip & Knee Implants

Timeline

23 May 2025	Recall initiated by company
2 Jul 2025	Classified by FDA	+40 days
9 Jul 2025	Published in enforcement report	+7 days

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

Reason for recall

Investigation has identified that the age of the nylon packaging material has caused a loss of integrity of some pouches.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

Apex Knee System. Model Numbers: KC-50090, KC-50097, KC-50110, KC-50117, KC-50130, KC-50135, KC-50137, KC-50150, KC-50155, KC-50157, KC-50170, KC-50175, KC-50177, KC-50190, KC-50197, KC-52104, KC-52554, KC-52574, KC-52774, KC-55223, KC-55243

Where it was distributed

US Nationwide distribution in the states of CA, CO, FL, IL, OK, TX, UT.

Nationwide California Colorado Florida Illinois Oklahoma Texas Utah

Questions about this recall

Why was it recalled?

Investigation has identified that the age of the nylon packaging material has caused a loss of integrity of some pouches.

Which lots are affected?

Model Number (Serial Numbers): KC-50090(580854, 582278), KC-50097(528456, 528457), KC-50110(531527, 532301, 586311), KC-50117(552924), KC-50130(528458, 548885, 548886, 548887, 548888, 573259), KC-50135(529093), KC-50137(527387, 528459, 555044, 568751), KC-50150(529072, 529094, 565748, 584973, 584974), KC-50155(586369), KC-50157(528460, 528461, 545943, 565831, 565832, 567009, 572398, 587261, 587262), KC-50170(528462, 529076, 550671, 585011), KC-50175(552532), KC-50177(529073, 588382), KC-50190(529074), KC-50197(548468, 548469, 548470), KC-52104(584975), KC-52554(589609), KC-52574(586115, 586117), KC-52774(584976), KC-55223(580117), KC-55243(580855).

Where was it sold?

US Nationwide distribution in the states of CA, CO, FL, IL, OK, TX, UT.

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.

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