Z-1527-2016Class II

Trinity Acetabular Shell

Name: Z-1527-2016 Trinity Acetabular Shell
Creator: Corin USA Limited
Published: 2016-01-29
License: https://open.fda.gov/license/

Corin USA / initiated 2016-01-29 / Terminated / root cause: packaging

FDA source

Corin USA Limited began a recall of Trinity Acetabular Shell Product Usage: Total Hip Replacement on 2016-01-29. FDA classified it as Class II and gives the reason as "Potential for abrasion of the sterile barrier pouches of the new packaging system". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1527-2016
Classification: Class II
Status: Terminated
Initiated: 2016-01-29
Posted: 2016-04-22
Terminated: 2019-12-16
Recalling firm: Corin USA
Product: Trinity Acetabular Shell Product Usage: Total Hip Replacement.
Product code: LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Reason for recall: Potential for abrasion of the sterile barrier pouches of the new packaging system.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Corin sent an Urgent Medical Device Recall letter dated February 3, 2016. The letter identified the affected product, problem and actions to be taken. On January 29, 2016, Eight (8) of 11 distributors were spoken to during a Corin National Sales Meeting informing them of the recall. The 3 remaining distributors were notified by phone calls same date. Also, on February 2, 2016 Corin sent a Recall Letter to their Foreign consignee informating them of the recall of the Trinity Acetabular Shell and the actions to be take by the costumers including the return of the Customer Response Form and Contact information as Corin LTD Compliance Director at +44 (0) 1285 649190 Monday thru Friday 8:30am to 5:00pm UK Time
Quantity in commerce: 629 devices in total
Distribution: 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.
Product codes and lots: Cluster Shell 044mm Taper Size 1, Lot Code: 320023; Cluster Shell 046mm Pager Size 2, Lot Code: 320018; Cluster Shell 048mm Taper Size 2, Lot Codes: 321691, 322402, 322981, 322982, 323745, 323746, 324298; Cluster Shell 050mm Taper Size 2, Lot Codes: 321954, 322753, 322980; Cluster Shell 050mm Taper Size 3, Lot Codes:

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1527-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1526-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-04	2016-04-22
Z-1527-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-04	2016-04-22
Z-1528-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-04	2016-04-22

Product code LZO

K123705Class IITrinity Non-Occluded Titanium Plasma Sprayed (Tps) Acetabular ShellsCorin USA / cleared 2013-02-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)