—#138747

Product

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

FDA product code: KXE — Prosthesis, Wrist, Hemi-, Ulnar
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K061146
Affected lot / code info: 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

Why it was recalled

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 (FDA determination)

Packaging change control

Action the firm took

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.

Recalling firm

Firm: Stryker Howmedica Osteonics Corp.
Address: 325 Corporate Dr, Mahwah, New Jersey 07430-2006

Distribution

Distribution pattern: Worldwide Distribution.

Timeline

Recall initiated: 2015-06-24
Posted by FDA: 2015-08-20
Terminated: 2016-04-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #138747. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.