Z-1667-2022Class II

TaperFit Stem, Size 0, 38mm OFFSET, 12/14 Taper + 188.550 Centraliser, For Cemented Use, REF 588.3800...

Name: Z-1667-2022 TaperFit Stem, Size 0, 38mm OFFSET, 12/14 Taper + 188.550 Centraliser, For Cemented Use, REF 588.3800...
Creator: Corin Ltd
Published: 2022-07-12
License: https://open.fda.gov/license/

Corin Limited / initiated 2022-07-12 / Terminated

FDA source

Corin Ltd began a recall of TaperFit Stem, Size 0, 38mm OFFSET, 12/14 Taper + 188.550 Centraliser, For Cemented Use, REF 588.3800. Orthopedic hip implant component on 2022-07-12. FDA classified it as Class II and gives the reason as "Some of the devices did not pass fatigue testing". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1667-2022
Classification: Class II
Status: Terminated
Initiated: 2022-07-12
Posted: 2022-08-31
Terminated: 2026-05-04
Recalling firm: Corin Limited
Product: TaperFit Stem, Size 0, 38mm OFFSET, 12/14 Taper + 188.550 Centraliser, For Cemented Use, REF 588.3800. Orthopedic hip implant component.
Product code: JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Reason for recall: Some of the devices did not pass fatigue testing.
FDA root cause: Under Investigation by firm
Action: The recalling firm issued the recall letter dated 7/8/2022 via email to the consignee on 7/12/2022. The recall letter described the potential issue and listed the affected product. The potential risk was reported and the actions to be carried out by the customer, which included return of the product from the field and completion of the acknowledgement form to be returned via email to confirm receipt of the letter.
Quantity in commerce: 1
Distribution: Distribution was made to NJ. There was no military/government distribution.
Product codes and lots: Model #588.3800, Lot #494754; UDI 05055343871065

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1667-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1667-2022	Class II	Terminated	Voluntary: Firm initiated	2022-09-07	2022-08-31

Product code JDI

K142761Class IICorin TaperFit Hip StemCorin USA / cleared 2015-04-03

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)