Z-2429-2015Class II

Recon, Radial Implant, Standard Stem, Size 1, Sterile, Do Not Reuse, Rx Only. Intended for replacement of the...

Name: Z-2429-2015 Recon, Radial Implant, Standard Stem, Size 1, Sterile, Do Not Reuse, Rx Only. Intended for replacement of the...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2015-06-24
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2015-06-24 / Terminated / root cause: packaging

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Recon, Radial Implant, Standard Stem, Size 1, Sterile, Do Not Reuse, Rx Only. Intended for replacement of the proximal end of the radius on 2015-06-24. FDA classified it as Class II and gives the reason as "Stryker is recalling rHead, uHead, Sigmoid Notch, Remotion, Radio Capitellum because packaging integrity (sterile barrier) of the packaging type KIT I may potentially be compromised by transportation". 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-2429-2015
Classification: Class II
Status: Terminated
Initiated: 2015-06-24
Posted: 2015-08-20
Terminated: 2016-04-29
Recalling firm: Howmedica Osteonics Corp
Product: Recon, Radial Implant, Standard Stem, Size 1, Sterile, Do Not Reuse, Rx Only. Intended for replacement of the proximal end of the radius.
Product code: JDB Prosthesis, Elbow, Semi-Constrained, Cemented
Reason for recall: Stryker is recalling rHead, uHead, Sigmoid Notch, Remotion, Radio Capitellum because packaging integrity (sterile barrier) of the packaging type KIT I may potentially be compromised by transportation.
Root cause tag: packaging
FDA root cause: Packaging change control
Action: Branches/Agencies were notified by Stryker of this action by e-mails on June 24, 2015 and an Urgent Medical Device Removal Letter/Acknowledgement Response Form dated June 25, 2015 was sent to the attention of the Risk Manager.
Quantity in commerce: 16992 total
Distribution: Worldwide Distribution.
Product codes and lots: Part Number: RCN-S1 (#1 Bipolar Stem Implant - Sterile packed) - Lot #'s 18566, 18567, 18568, 18697, 18837, 22297901, 22297902, 22848901, 19099-S2, 19101-S2, 19684-S2, 19685-S2, 19716-S2, 19769-S2, 19803-S2, 19846-S2, 19918-S2, 19919-S2 and 19982-S2; Part Number: RCN-S2 (#2 Bipolar Stem Implant - Sterile packed) - Lot #'s 18295, 18753, 18839, 22098402, 22298001, 22298002, 22614201, 22614202, 22849101, 23068301, 19664-S2, 19718-S2, 19719-S2, 19770-S2, 19771-S2, 19772-S2, 19805-S2, 19847-S2, 19848-S2, 19849-S2, 19850-S2 and 19921-S2; Part Number: RCN-S3 (#3 Bipolar Stem Implant - Sterile packed) - Lot #'s 18296, 18754, 22298101, 22298102, 22614401, 22614402, 22849301, 23068501, 23068502, 23479701, 19665-S2, 19720-S2, 19721-S2, 19722-S2, 19774-S2, 19775-S2, 19776-S2, 19806-S2, 19852-S2, 19853-S2 and R237901; Part Number: RCN-S4 (#4 Bipolar Stem Implant - Sterile packed) - Lot #'s 18885, 18886, 22298201, 22298202, 22614501, 22614502, 22849501, 23068601, 23479901, 19666-S2, 19724-S2, 19725-S2, 19777-S2, 19808-S2, 19855-S2, 19856-S2, 19922-S2, 19988-S2 and R23479901 Part Number: RHA-S1 (Radial Stem Implant #1 - Sterile packed) - Lot #'s 18374, 18387, 18500, 18574, 18705, 18706, 18845, 18846, 18847, 22613001, 22850001, 23069001, 19111-S2, 19112-S2, 19726-S2, 19778-S2 and 19857-S2; Part Number: RHA-S2 (Radial Stem Implant #2 - Sterile packed) - Lot #'s 22098802, 22279401, 22279402, 22613201, 22850201, 23069201, 23493402, 109667-S2, 19780-S2 19781-S2, 19810-S2, 19859-S2, 19860-S2, 19861-S2, 19923-S2 and R23493402; Part Number: RHA-S3 (Radial Stem Implant #3 - Sterile packed) - Lot #'s 18855, 22098902, 22279501, 22279502, 22613401, 22613402, 22850401, 23069401, 23226201, 23490201, 19687-S2, 19727-S2, 19728-S2, 19729-S2, 19783-S2, 19811-S2, 19812-S2, 19862-S2, 19863-S2, 19924-S2, 19925-S2 and R23490201; Part Number: RHA-S4 (Radial Stem Implant #4 - Sterile packed) - Lot #'s 18378, 22279601, 22613601, 22613602, 22850601, 23069501, 23226301, 23491501, 19668-S2, 19784-S2, 19814-S2, 19864-S2, 19926-S2, 19927-S2 and R23491501; Part Number: WA/C-L (Wrist Carpal Implant Large) - Lot #'s 23689901, 23946601, 23946602, 23946603, 24056601 and 19064-S2; Part Number: WA/C-M (Wrist Carpal Implant Medium) - Lot #'s 22296901, 22296902, 22595501, 22595502, 22758401, 22758402, 23041201, 23216201, 23689801, 23689802, 23689803, 23946801, 23946802, 23946803, 24056701, 24056702 and 24056703; Part Number: WA/C-S (Wrist Carpal Implant Small) - Lot #'s 22297001, 22297002, 22431101, 22595601, 225965602, 22758501, 22758502, 23041301, 23689701, 23689702, 23689703, 23946701, 23946702, 23946703, 24056801, 24056802 and 24056803; Part Number: WA/R-LL (Wrist Left Radial Implant Large) - Lot #'s 18872, 23946901, 23946902, 23946903, 24056901, 19061-S2, 19605-S2, 19828-S2, 19829-S2, 19955-S2, R19605-S2, R19828-S2 and R19829-S2; Part Number: WA/R-LM (Wrist Left Radial Implant Medium) - Lot #'s 22595701, 22758601, 22758602, 23041401, 23690401, 23690401, 23690402, 23690403, 24057001, 19062-S2, R23690401, R23690402 and R23690403; Part Number: WA/R-LS (Wrist Left Radial Implant Small) - Lot #'s 22758701, 22758702, 23041501, 23216301, 23690501, 23690502, 24057101, 24057102, R23690501 and R23690502; Part Number: WA/R-LXS (Distal Radial Comp X-Small, Left, Sterile) - Lot #'s 18794, 18873, 22758801, 22758802 and 23041601; Part Number: WA/R-RL (Wrist Right Radial Implant Large) - Lot #'s 18795, 23690001, 23690002, 23690003, 24057201, R23690001, R23690002 and R23690003; Part Number: WA/R-RM (Wrist Right Radial Implant Medium) - Lot #'s 15892, 22297101, 22595801, 22758901, 22758902, 23041701, 23261401, 23690101, 23690102, 23690103, 23947101, 23947102, 24057301, R23690101 and R23690102; Part Number: WA/R-Rs (Wrist Right Radial Implant Small) - Lot #'s 22297201, 22595901, 22595901, 22595902, 22759001, 22759002, 23041801, 23261501, 23690201, 23690202, 23690203, 23947001, 23947002, 23947003, 23947004, 24057401, 19073-S2, R23690201 and R23690202; Part Number: WA/R-RXS (Distal Radial Comp X-Small, Right, Sterile) - Lot #'s 18796, 18874, 22596001, 22759101, 22759102, 23041901, 23690301, 23690302, 23690303, 23947201, 24057501, R23690301, R23690302 and R23690303.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2429-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2426-2015	Class II	Terminated	Voluntary: Firm initiated	2015-08-26	2015-08-20
Z-2427-2015	Class II	Terminated	Voluntary: Firm initiated	2015-08-26	2015-08-20
Z-2428-2015	Class II	Terminated	Voluntary: Firm initiated	2015-08-26	2015-08-20
Z-2429-2015	Class II	Terminated	Voluntary: Firm initiated	2015-08-26	2015-08-20
Z-2430-2015	Class II	Terminated	Voluntary: Firm initiated	2015-08-26	2015-08-20

Product code JDB

K102180Class IIRhead Radial Head Extended StemsSmall Bone Innovations, Inc. / cleared 2010-12-20

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)