Z-1629-2024Class II

TRIDENTII PSL CLUSTER50D- Indicated for use in primary and revision patients at high risk of hip dislocation...

Name: Z-1629-2024 TRIDENTII PSL CLUSTER50D- Indicated for use in primary and revision patients at high risk of hip dislocation...
Creator: Howmedica Osteonics Corp.
Published: 2024-02-27
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2024-02-27 / Open, Classified

FDA source

Howmedica Osteonics Corp. began a recall of TRIDENTII PSL CLUSTER50D- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-50D on 2024-02-27. FDA classified it as Class II and gives the reason as "The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1629-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-02-27
Posted: 2024-04-25
Recalling firm: Howmedica Osteonics Corp
Product: TRIDENTII PSL CLUSTER50D- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-50D
Product code: LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Reason for recall: The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
FDA root cause: Under Investigation by firm
Action: Stryker issued Urgent Medical Device Recall (UMDR) PFA 3529813 by Sedgwick on Feb. 27, 2024, via UPS 2-day air. An OUS customer notification will also be issued at the country level. Letter states reason for recall and action to take: Technical and medical assessments are currently underway to determine any potential hazards and harms associated with the use of an impacted Trident II Acetabular Shell. An updated communication will be forwarded upon completion of the internal investigation of this issue. 1. Please inform users of this Urgent Medical Device Recall and forward this notice to all individuals who need to be made aware or organizations who have consigned product. 2. Immediately check all stock areas and/or operating room storage to determine if any devices from the affected product list are at your facility. 3. Quarantine and discontinue use of the recalled devices identified in the affected product list. 4. Complete and sign the enclosed Urgent Medical Device Recall Business Reply Form and email to " Medical Facility: Please sign the Business Reply Form and email to: [email protected] / Fax: (833) 237-1022 " Stryker Branch/Agency: please sign the AdobeSign form arriving to you via email. 5. Please contact your Local Sales Office or your Stryker Sales Representative directly for product replacement and inventory questions. 6. Please return the devices to Stryker using the following address: Stryker Orthopaedics/PFA Product Returns Attn: Distribution Inventory Team 325 Corporate Drive Dock M-East Mahwah, NJ 07430 Ref. PFA 3529813 If you have any questions or concerns after reviewing this letter, please contact Customer Service at (888)-756-7846. For questions pertaining to the recall, email [email protected]
Quantity in commerce: 0
Distribution: Nationwide Foreign: Netherlands, Canada, Singapore, Spain, Sweden, UK
Product codes and lots: UDI-DI:(01)07613327381009(17)290313(10) Lot Number: 14593551 15432653 15432651

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1629-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1621-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-01	2024-04-25
Z-1622-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-01	2024-04-25
Z-1623-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-01	2024-04-25
Z-1624-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-01	2024-04-25
Z-1625-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-01	2024-04-25
Z-1626-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-01	2024-04-25
Z-1627-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-01	2024-04-25
Z-1628-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-01	2024-04-25
Z-1629-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-01	2024-04-25
Z-1630-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-01	2024-04-25
Z-1631-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-01	2024-04-25
Z-1632-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-01	2024-04-25

Product code LPH

K171768Class IITrident® II Acetabular SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics / cleared 2017-10-02

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)