Stryker Howmedica Osteonics Corp.: uHead, Ulnar Implant, Standard Stem, Size 1, Sterile, Rx Only. Intended for replacement of the distal radioulnar joint following ulnar head resection arthroplasty.

Recall number

Z-2427-2015

Recalling firm

Stryker Howmedica Osteonics Corp.

Product

uHead, Ulnar Implant, Standard Stem, Size 1, Sterile, Rx Only. Intended for replacement of the distal radioulnar joint following ulnar head resection arthroplasty.

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: UHA-S1 (Ulnar Stem Implant #1 Sterile Packed) - Lot #'s 17584, 17585, 22217301, 22217302, 23470801, 19066-S2, 19417-S2, 19418-S2, 1973-S2, 19732-S2, 19785-S2, 19815-S2 and $23470801; Part Number: UHA-S120 (Recon Ulnar Stem Implant #1, 20mm Extension) - Lot #'s 16725, 16726, 18577, 18757, 18758, 18759, 18867, 23124001, 19056-S2, 19786-S2, 19816-S2, 19928-S2 and 19929-S2; Part Number: UHA-S2 (Ulnar Stem Implant #2 Sterile Packed) - Lot #'s 16714, 16715, 18760, 22760101, 22760102, 23124101, 23124102, 23470901, 19669-S2, 19817-S2, 19866-S2 and R23470901; Part Number: UHA-S220 (Recon Ulnar Stem Implant #2, 20mm Extention) - Lot #'s 16720, 16721, 18415, 18761, 18762, 18763, 18764, 18765, 18868, 23124201, 19122-S2, 19787-S2, 19818-S2, 19930-S2 and 19932-S2; Part Number: UHA-S3 (Ulnar Stem Implant #3 Sterile Packed) - Lot #'s 16716, 16717, 22760201, 22760202, 22760203, 23124301, 23124302, 19788-S2, 19789-S2, 19818-S2, 19820-S2, 19821-S2, 19867-S2 and 19868-S2; Part Number: UHA-S320 (Recon Ulnar Stem Implant #3, 20mm Extention) - Lot #'s16722, 16723, 18869, 19065-S2, 19157-S2, 19733-S2, 19790-S2 and 19933-S2; Part Number: UHA-S4 (Ulnar Stem Implant #4 Sterile Packed) - Lot #'s 16718, 16719, 18766, 18865, 18866, 19156-S2, 19670-S2, 19671-S2, 19672-S2, 19734-S2, 19822-S2 and 19869-S2; Part Number: UHA-S420 (Recon Ulnar Stem Implant #4, 20mm Extention) - Lot #'s 16724, 18578, 18767, 18768, 18870, 18871, 22760301, 19072-S2, 19100-S2, 19158-S2, 19791-S2, 19823-S2, 19934-S2 and 19935-S2

510(k) numbers

["K061146"]

PMA numbers

not on file

Product code

KXE

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

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