Stryker Recalls 18 Hinge Coupling Units Due to Packaging Error
Stryker GmbH is recalling 18 Hinge Coupling Hoffmann LRF units because connecting nuts were incorrectly packed in hinge coupling packaging.
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, but the source text describes a packaging error (wrong parts picked) without reporting any injuries, illnesses, or specific structural defects that would elevate the severity to High or Severe.
Plain-English summary
Stryker GmbH is recalling 18 units of the Hinge Coupling Hoffmann LRF (Catalog # 4933-0-800, Lot # L23745). This medical device is intended for the fixation of fractures, joint contractures, fusions, limb lengthening, deformity correction, bone and soft tissue reconstruction in pediatric patients and adults.
The recall was initiated because the wrong parts were picked for packaging. Specifically, connecting nuts were packed in the packaging labeled with hinge coupling. The agency has classified this as a Class II recall.
The affected units were distributed nationwide in the USA. Healthcare providers and patients should stop using the affected units and contact Stryker GmbH for further instructions.
The recalled product
- Product
- Hinge Coupling Hoffmann LRF Catalog # 4933-0-800 Intended for fixation of fractures, joint contractures, fusions, limb lengthening, deformity correction, bone and soft tissue reconstruction in pediatric patients and adults.
- Manufacturer
- Stryker GmbH
- Category
- Medical Device — Orthopedic
- Affected units
- 18
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 (1)
- Lot # L23745
Distribution
Distributed nationwide across the United States.
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