Z-2253-2014Class II

Pivot Bipolar Cup 22x42/43-51/53mm, REF 133-YYYY

Name: Z-2253-2014 Pivot Bipolar Cup 22x42/43-51/53mm, REF 133-YYYY
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 Pivot Bipolar Cup 22x42/43-51/53mm, REF 133-YYYY Product Usage: Used in a hemiarthroplasty procedure as the bearing surface to articulate with both the CoCr... 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-2253-2014
Classification: Class II
Status: Terminated
Initiated: 2014-07-11
Posted: 2014-08-17
Terminated: 2014-10-06
Recalling firm: Ortho Development Corp.
Product: Pivot Bipolar Cup 22x42/43-51/53mm, REF 133-YYYY Product Usage: Used in a hemiarthroplasty procedure as the bearing surface to articulate with both the CoCr femoral head and the natural acetabulum
Product code: KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
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: 188
Distribution: Worldwide Distribution - US Nationwide and the country of Japan. No military/govt/VA consignees.
Product codes and lots: Pivot Bipolar Cup 22x42mm,Part 133-2242,Lot A136254,Pivot Bipolar Cup 22x43mm,Part 133-2243,Lot A136256,Pivot Bipolar Cup 22x43mm,Part 133-2243,Lot A136255,Pivot Bipolar Cup 22x44mm,Part 133-2244,Lot A136257,Pivot Bipolar Cup 22x45mm,Part 133-2245,Lot A136258,Pivot Bipolar Cup 22x46mm,Part 133-2246,Lot A136259,Pivot Bipolar Cup 22x46mm,Part 133-2246,Lot A136260,Pivot Bipolar Cup 22x47mm,Part 133-2247,Lot A136261,Pivot Bipolar Cup 22x48mm,Part 133-2248,Lot A136262,Pivot Bipolar Cup 22x49mm,Part 133-2249,Lot A136263,Pivot Bipolar Cup 22x50mm,Part 133-2250,Lot A136265,Pivot Bipolar Cup 22x51mm,Part 133-2251,Lot A136266,Pivot Bipolar Cup 22x53mm,Part 133-2253,Lot A136269,Pivot Bipolar Cup 22x53mm,Part 133-2253,Lot A136268,Pivot Bipolar Cup 22x53mm,Part 133-2253,Lot A136267,Pivot Bipolar Cup 22x53mm,Part 133-2253,Lot A136270,

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2253-2014
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 KWY

K050966Class IIPivot Bipolar Femoral HeadOrtho Development Corp. / cleared 2005-07-07

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)