Z-1043-2015Class II

Trident PSL HA Solid Back 50 mm Includes Dome Hole Plug Ref 540-11-50E Intended for cementless application in...

Name: Z-1043-2015 Trident PSL HA Solid Back 50 mm Includes Dome Hole Plug Ref 540-11-50E Intended for cementless application in...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2014-12-15
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2014-12-15 / Terminated / root cause: manufacturing process

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Trident PSL HA Solid Back 50 mm Includes Dome Hole Plug Ref 540-11-50E Intended for cementless application in a total hip arthroplasty procedure. This system... on 2014-12-15. FDA classified it as Class II and gives the reason as "Five customer complaints were received for the same batch of Trident PSL Shells (part number 540-11-50E lot 49073501) alleging that when the packages were opened there were no dome holes plugs present". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1043-2015
Classification: Class II
Status: Terminated
Initiated: 2014-12-15
Posted: 2015-02-03
Terminated: 2016-09-22
Recalling firm: Howmedica Osteonics Corp
Product: Trident PSL HA Solid Back 50 mm Includes Dome Hole Plug Ref 540-11-50E Intended for cementless application in a total hip arthroplasty procedure. This system is a two piece ( a shell and a liner) design that is assembled during surgery. The shell is press-fit into the patients prepared acetabulum and a linger (polyethylene or alumina ceramic) is then locked into the shell. The femoral head component of the total hip system articulates with the acetabular liner.
Product code: MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Reason for recall: Five customer complaints were received for the same batch of Trident PSL Shells (part number 540-11-50E lot 49073501) alleging that when the packages were opened there were no dome holes plugs present.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Stryker sent an Urgent Medical Device letter dated January 7, 2015, with a Recall Notification/Acknowledgement Form via Fed Ex to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to complete and return the attached Product Recall Acknowledgement Form to [email protected] or fax to 1-855-251-3635. Customers should return the affected product to: Attention: Regulatory Compliance Stryker Orthopaedics 325 Corporate Drive Mahwah, New Jersey 07430 Customers with questions should call 201-831-6365. For questions regarding this recall call 201-831-5000.
Quantity in commerce: seven units
Distribution: Nationwide Distribution including NY, OH, PA, and TX.
Product codes and lots: 510K 983382 Lot code 49073501

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1043-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1043-2015	Class II	Terminated	Voluntary: Firm initiated	2015-02-11	2015-02-03

Product code MEH

K983382Class IIOsteonics Ha Generation II Acetabular Component SystemOsteonics Corp. / cleared 1998-12-11

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)