Z-2363-2015Class II

ReUnion TSA Shoulder System, Standard SR Humeral Head Trial, 48X18, Catalog number 5901-S-4818. Orthopedic...

Name: Z-2363-2015 ReUnion TSA Shoulder System, Standard SR Humeral Head Trial, 48X18, Catalog number 5901-S-4818. Orthopedic...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2015-05-12
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2015-05-12 / Terminated / root cause: manufacturing process

FDA source

Stryker Howmedica Osteonics Corp. began a recall of ReUnion TSA Shoulder System, Standard SR Humeral Head Trial, 48X18, Catalog number 5901-S-4818. Orthopedic manual surgical instrument. Howmedica Osteonics... on 2015-05-12. FDA classified it as Class II and gives the reason as "A package labeled as Part #5901-S-4818, Lot MAC7C14, standard humeral head trial, contained part # 5901-E-4818 Lot MAC7C14, offset humeral head trial". 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-2363-2015
Classification: Class II
Status: Terminated
Initiated: 2015-05-12
Posted: 2015-08-10
Terminated: 2016-10-05
Recalling firm: Howmedica Osteonics Corp
Product: ReUnion TSA Shoulder System, Standard SR Humeral Head Trial, 48X18, Catalog number 5901-S-4818. Orthopedic manual surgical instrument. Howmedica Osteonics Corp. A Subsidiary of Stryker Corp. Stryker France Non-sterile Made in Cork Ireland
Product code: KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Reason for recall: A package labeled as Part #5901-S-4818, Lot MAC7C14, standard humeral head trial, contained part # 5901-E-4818 Lot MAC7C14, offset humeral head trial.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Stryker Orthopaedics notified their branches/agencies via email on 5/12/2015 and sent notification letters and product accountability forms to hospital risk management/branches on 7/15/2015 and 7/16/2015
Quantity in commerce: 21 units
Distribution: US Nationwide
Product codes and lots: Catalog #5901-S-4818, Lot MAC7C14.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2363-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2363-2015	Class II	Terminated	Voluntary: Firm initiated	2015-08-19	2015-08-10

Product code KWS

K103835Class IIReunion Tsa System-Humeral Press-Fit & Cemented Stems Model 5569-Yy-20Xx (Yy=p,c; Xx=07-17,06L-12L) Reunion Tsa System NHowmedica Osteonics Corp. / cleared 2011-05-05

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)