Stryker Gamma Guide Pin Recalled for Potential Packaging Seal Integrity Issues
Stryker Howmedica Osteonics Corp. is recalling Gamma Guide Pins because a packaging review indicated that the seal integrity of the pouch may be decreased.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 the hazard is a potential packaging defect (decreased seal integrity) without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Stryker Howmedica Osteonics Corp. is recalling the Stryker Gamma Guide Pin, 4x400 mm. This medical device is intended for the temporary stabilization of bone segments or fragments. The recall involves 147,838 units distributed nationwide in the United States.
The recall was initiated after a review of the packaging determined that the seal integrity of the pouch may be decreased. The affected products are identified by catalog number 1213-9091S. The recall includes all lots distributed before November 10, 2015, that have a non-expired 5-year shelf life.
Healthcare providers and facilities should stop using the affected Gamma Guide Pins and contact Stryker Howmedica Osteonics Corp. for further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- Stryker, Gamma Guide Pin, 4x400 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
- Manufacturer
- Stryker Howmedica Osteonics Corp.
- Affected units
- 147,838
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 (2)
- Catalog number 1213-9091S
- All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 18 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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