CLASS II Device recall · Reported 4 May 2016 · FDA Enforcement Report

Trinity Acetabular Shell recalled by Corin USA

Corin USA is recalling Trinity Acetabular Shell, distributed nationwide in the US. The recall was initiated on 29 Jan 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesNo Hole Shell 048mm Taper Size 2, Lot Codes: 322986, 323743, 320026, 322977, 323744; No Hole Shell 052mm Taper Size 3, Lot Codes: 322396, 322971, 322403, 322984, 322985, 323750.

Quantity recalled629 devices in total

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-1528-2016
FDA event ID: 73205
Recalling firm: Corin USA, Tampa, FL
Classification: Class II
Status: Terminated
Recall initiated: 29 Jan 2016
FDA classified: 22 Apr 2016
Reported: 4 May 2016
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Sterility
Device type: Hip & Knee Implants

Timeline

29 Jan 2016	Recall initiated by company
22 Apr 2016	Classified by FDA	+84 days
4 May 2016	Published in enforcement report	+12 days

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

Reason for recall

Potential for abrasion of the sterile barrier pouches of the new packaging system.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Trinity Acetabular Shell Product Usage Total Hip Replacement.

Where it was distributed

Worldwide Distribution - US Nationwide in the states of CA, FL, ID, TX, OK, OH, MA, and NC and the countries of Australia Belgium, Egypt, Germany, Ghana, Italy, Japan, Poland, South Africa and UK.

Nationwide California Florida Idaho Massachusetts North Carolina Ohio Oklahoma Texas

Questions about this recall

Is Trinity Acetabular Shell recalled?

Yes. Corin USA recalled Trinity Acetabular Shell on 29 Jan 2016. The recall is Class II and its status is Terminated. Recall number Z-1528-2016.

Why was it recalled?

Potential for abrasion of the sterile barrier pouches of the new packaging system.

Which lots are affected?

No Hole Shell 048mm Taper Size 2, Lot Codes: 322986, 323743, 320026, 322977, 323744; No Hole Shell 052mm Taper Size 3, Lot Codes: 322396, 322971, 322403, 322984, 322985, 323750.

Where was it sold?

Worldwide Distribution - US Nationwide in the states of CA, FL, ID, TX, OK, OH, MA, and NC and the countries of Australia Belgium, Egypt, Germany, Ghana, Italy, Japan, Poland, South Africa and UK.

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

More recalls from Corin USA

All 3

Reported	Class	Recall	Company	Reason	Where
4 May 2016Device	CLASS II	Trinity Acetabular Shell recalled by Corin USA	Corin USA	Sterility	Nationwide
4 May 2016Device	CLASS II	Trinity Acetabular System recalled by Corin USA	Corin USA	Sterility	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	Nitrosamine Impurity	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)	Lead & Heavy Metals	IN
12 Aug 2026Device	CLASS II	U2 Total Knee System Femoral offset bushing recalled	United Orthopedic	Device Malfunction	Nationwide