Stryker Recalls Wrist Implants Due to Potential Sterile Barrier Compromise
Stryker is recalling specific wrist implant models because their sterile packaging may be compromised during transportation.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a potential sterile barrier compromise in a medical device, which poses a risk of infection (risk-of-harm product) but no injuries or illnesses have been reported in the source text.
Plain-English summary
Stryker Howmedica Osteonics Corp. is recalling specific models of wrist implants, including rHead, uHead, Sigmoid Notch, Remotion, and Radio Capitellum. The recall is due to a potential compromise in the integrity of the sterile barrier packaging (packaging type KIT I) caused by transportation.
The affected products are intended for orthopedic use and are distributed worldwide. The source text does not specify the exact number of units affected, specific lot numbers, or the date of the recall. No illnesses or injuries have been reported in the source text.
Consumers and healthcare providers should stop using the affected products and contact Stryker for further instructions on replacement or return. The FDA classifies this as a Class II recall, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Recon, Radial Implant, Standard Stem, Size 1, Sterile, Do Not Reuse, Rx Only. Intended for replacement of the proximal end of the radius.
- 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: RCN-S1 (#1 Bipolar Stem Implant - Sterile packed) - Lot #'s 18566
- 18567
- 18568
- 18697
- 18837
- 22297901
- 22297902
- 22848901
- 19099-S2
- 19101-S2
- 19684-S2
- 19685-S2
- 19716-S2
- 19769-S2
- 19803-S2
- 19846-S2
- 19918-S2
- 19919-S2 and 19982-S2
- Part Number: RCN-S2 (#2 Bipolar Stem Implant - Sterile packed) - Lot #'s 18295
- 18753
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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