Z-2254-2014Class II

Patella 38mm, REF164-0038

Name: Z-2254-2014 Patella 38mm, REF164-0038
Creator: Ortho Development Corporation
Published: 2014-07-11
License: https://open.fda.gov/license/

Ortho Development Corp. / initiated 2014-07-11 / Terminated / root cause: packaging

FDA source

Ortho Development Corporation began a recall of Patella 38mm, REF164-0038 Product Usage: UHMWPE component used in a TKA procedure to resurface the patella and serve as a bearing surface for sliding contact... on 2014-07-11. FDA classified it as Class II and gives the reason as "Ortho Development is recalling various Pivot Bipolar Cup, Patella, PS Tibial Insert, UC Tibila Insert, and CK Tibil Insert because the foil pouches did not properly seal, allowing air to seep back into the pouch after...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2254-2014
Classification: Class II
Status: Terminated
Initiated: 2014-07-11
Posted: 2014-08-17
Terminated: 2014-10-06
Recalling firm: Ortho Development Corp.
Product: Patella 38mm, REF164-0038 Product Usage: UHMWPE component used in a TKA procedure to resurface the patella and serve as a bearing surface for sliding contact with the femoral component
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: Ortho Development is recalling various Pivot Bipolar Cup, Patella, PS Tibial Insert, UC Tibila Insert, and CK Tibil Insert because the foil pouches did not properly seal, allowing air to seep back into the pouch after sealing which increases the risk that the material properties of the implant would be substantially degraded due to oxidation.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Ortho Development notified all affected consignees/distributors of the recall via email on July 11, 2014 which included a list of the affected product (part numbers, lot numbers and quantities) under their control. An RMA number and return shipping label were also included with the email. Emails were followed up with phone calls to verify receipt of the notification.
Quantity in commerce: 14
Distribution: Worldwide Distribution - US Nationwide and the country of Japan. No military/govt/VA consignees.
Product codes and lots: Patella 38mm Part 164-0038, Lot A135844

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2254-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2253-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-27	2014-08-17
Z-2254-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-27	2014-08-17
Z-2255-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-27	2014-08-17
Z-2256-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-27	2014-08-17
Z-2257-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-27	2014-08-17

Product code JWH

K994370Class IIOrtho Development Balanced Knee SystemOrtho Development Corp. / cleared 2000-03-24

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)