Synthes Recalls 4.5mm Multiloc Screws Due to Incorrect Size Labeling
Synthes USA is recalling two lots 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 labeling error (incorrect size) without reported injuries or illnesses, fitting the criteria for a moderate severity recall.
Plain-English summary
Synthes USA HQ, Inc. is recalling two lots of 4.5mm TI Multiloc Screws, Length 28MM-Sterile. The recall was initiated because the products were incorrectly labeled regarding the screw size.
The affected products are identified by Lot #2721745, with an expiration date of 4/29/2012, and reference number 04.019.028S. The total quantity involved in the recall is 20 units. These medical devices are used with a Multiloc PHN for the treatment of proximal humerus fractures.
The products were distributed nationwide, including in the states of Arizona, California, Florida, Georgia, Illinois, Louisiana, Maryland, Minnesota, New Jersey, New York, Ohio, Pennsylvania, Tennessee, Texas, and Virginia. Healthcare providers and patients should check their inventory or medical records for these specific lot numbers and reference codes to ensure the correct device is used.
The recalled product
- Product
- 4.5mm TI Multiloc Screw Length 28MM-Sterile Expiration: 04/29/2012 REF 04.019.028S Manufactured or Distributed by Synthes (USA) 1101 Synthes Avenue, Monument CO 80132 4.5MM TI Multiloc Screw Length 28MM-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 #2721745 Expiration 4/29/2012 REF 04.019.028S
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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