Synthes Recalls 4.5mm Multiloc Screws Due to Incorrect Size Labeling
Synthes USA is recalling 20 units of 4.5mm Multiloc Screws because they were incorrectly labeled with the wrong screw size.
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 involves a minor labeling error regarding screw size, which fits the criteria for a moderate severity recall without reported injuries.
Plain-English summary
Synthes USA HQ, Inc. is recalling 20 units of 4.5mm TI Multiloc Screws, Length 38MM-Sterile, Reference 04.019.038S. The recall is due to incorrect labeling of the screw size.
The affected product is Lot #2724103 with an expiration date of 04/29/2012. These screws are used with a Multiloc PHN for the treatment of proximal humerus fractures. The products were distributed nationwide, including in Arizona, California, Florida, Georgia, Illinois, Louisiana, Maryland, Minnesota, New Jersey, New York, Ohio, Pennsylvania, Tennessee, Texas, and Virginia.
Healthcare providers and facilities should stop using the affected screws and contact Synthes USA for further instructions.
The recalled product
- Product
- 4.5mm TI Multiloc Screw Length 38MM-Sterile Expiration: 04/29/2012 REF 04.019.038S Manufactured or Distributed by Synthes (USA) 1101 Synthes Avenue, Monument CO 80132 4.5MM TI Multiloc Screw Length 38MM-Sterile Ref 04.019,038S. The Multiloc Screw 4.5 is used with a…
- Manufacturer
- Synthes USA HQ, Inc.
- Hazard
- Affected units
- 20
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 #2724103 Expiration 4/29/2012 REF 04.019.038S
Distribution
Part of a larger recall action
This product is one of 2 recalled by Synthes USA HQ, Inc. 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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