Stryker Howmedica Osteonics Corp.: Recon, Radial Implant, Standard Stem, Size 1, Sterile, Do Not Reuse, Rx Only. Intended for replacement of the proximal end of the radius.

Recall number

Z-2429-2015

Recalling firm

Stryker 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.

Status

Terminated

Initiated

2015-06-24

Posted

2015-08-20

Terminated

2016-04-29

Reason

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

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

16992 total

Distribution

Worldwide Distribution.

Lot, serial or model codes

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.

510(k) numbers

["K102180"]

PMA numbers

not on file

Product code

JDB

Firm FEI

3003070421

Firm city

Mahwah

Firm state

NJ

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

Copy