uHead, Ulnar Implant, Standard Stem, Size 1, Sterile, Rx Only. Intended for replacement of the distal radioulnar joint following ulnar head resection arthroplasty.
This recall has been terminated (originally issued August 20, 2015).
- Recall Initiated
- June 24, 2015
- Posted
- August 20, 2015
- Terminated
- April 29, 2016
- Recall Number
- Z-2427-2015
- Quantity
- 16992 total
- Firm Location
- Mahwah, NJ
- Official Source
- View on FDA website ↗
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.
Distribution
Worldwide Distribution.
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
Root Cause
Packaging change control
Action Taken
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.