uHead, Ulnar Implant, Standard Stem recall: Sterility Concern
uHead, Ulnar Implant, Standard Stem, Size 1, Sterile, Rx Only. Intended for replacement of the distal radioulnar joint following ulnar head resection…
Why was uHead, Ulnar Implant, Standard Stem 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- uHead, Ulnar Implant, Standard Stem, Size 1, Sterile, Rx Only. Intended for replacement of the distal radioulnar joint following ulnar head resection…
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Quantity
- 16992 total
- Distribution
- Worldwide Distribution.
- Recall date
- August 26, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)