Z-2281-2016Class II

Stryker Orthopaedics Trident Constrained Liner Inserter/Impactor Tip, 22 mm, 28 mm, and 32 mm. Non Sterile...

Name: Z-2281-2016 Stryker Orthopaedics Trident Constrained Liner Inserter/Impactor Tip, 22 mm, 28 mm, and 32 mm. Non Sterile...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2016-06-03
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2016-06-03 / Terminated / root cause: manufacturing process

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Stryker Orthopaedics Trident Constrained Liner Inserter/Impactor Tip, 22 mm, 28 mm, and 32 mm. Non Sterile Catalog Numbers 2199-2022, 2199-2028 and 2199-2032... on 2016-06-03. FDA classified it as Class II and gives the reason as "Impactors do not meet the required sterility assurance level (SAL) of 10-6 when using the recommended steam sterilization method". 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-2281-2016
Classification: Class II
Status: Terminated
Initiated: 2016-06-03
Posted: 2016-07-25
Terminated: 2018-08-01
Recalling firm: Howmedica Osteonics Corp
Product: Stryker Orthopaedics Trident Constrained Liner Inserter/Impactor Tip, 22 mm, 28 mm, and 32 mm. Non Sterile Catalog Numbers 2199-2022, 2199-2028 and 2199-2032. For use in total hip arthroplasty.
Product code: LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Reason for recall: Impactors do not meet the required sterility assurance level (SAL) of 10-6 when using the recommended steam sterilization method.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: Stryker notified its branches/agencies of this recall by e-mail on May 26, 2016. They were asked to quarantine the affected devices. Stryker sent a recall letter and business reply form dated June 3, 2016 to their affected customers via UPS. Stericycle will be handling the returns.
Quantity in commerce: 1,864 units
Distribution: Worldwide distribution. US nationwide (AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MS, NJ, NY, OH, PA, TX, WA, WI, WV), Sweden, South Africa, Chile, Australia, New Zealand, Canada, United Kingdom, Switzerland, Colombia, and Poland.
Product codes and lots: Catalog Nos. 2199-2022, 2199-2028 and 2199-2032 All lots manufactured from May 30, 2012

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2281-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2281-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-03	2016-07-25

Product code LPH

K151264Class IIRestoration Anatomic ShellStryker Orthopaedics / cleared 2015-08-10

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)