Stryker Recalls uHead and Other Ulnar Implants Due to Packaging Concerns
Stryker is recalling specific ulnar implants because the sterile packaging may be compromised by transportation.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a potential sterile barrier compromise without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Stryker Howmedica Osteonics Corp. is recalling specific lots of uHead, rHead, Sigmoid Notch, Remotion, and Radio Capitellum implants. The recall is due to a potential compromise in the sterile barrier of the KIT I packaging type, which may have occurred during transportation.
The affected products are intended for orthopedic use, including the replacement of the distal radioulnar joint. The recall covers 16,992 total units that were distributed worldwide. Specific part numbers and lot numbers are listed in the official recall documentation.
Consumers and healthcare providers should stop using the affected lots and contact Stryker for further instructions. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- uHead, Ulnar Implant, Standard Stem, Size 1, Sterile, Rx Only. Intended for replacement of the distal radioulnar joint following ulnar head resection arthroplasty.
- Manufacturer
- Stryker Howmedica Osteonics Corp.
- Affected units
- 16,992
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 5 recalled by Stryker Howmedica Osteonics Corp. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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