Synthes Periprosthetic Locking Screw Recalled for Post-Expiration Shipment
Synthes (USA) Products LLC is recalling 15 units of 5.0 mm Periprosthetic Locking Screws shipped after their expiration date.
What this means for you
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: This is a voluntary precautionary recall for a documentation/shipping error (post-expiration shipment) with no reported illnesses or injuries, fitting the Moderate severity criteria.
Plain-English summary
Synthes (USA) Products LLC is recalling 15 units of 5.0 mm Periprosthetic Locking Screws, Self-tapping, 12 mm Sterile (Catalog ID # 02.221.462S). The specific lot number is 5539094, with a manufacture date of 07/02/2007 and an expiration date of 05/31/2012.
The recall was initiated because the lot was shipped after the expiration date of May 31, 2012. The source text notes that the label on the product displays the correct expiration date. The product is indicated for the fixation of various long bones.
The affected units were distributed in Illinois (IL) and Indiana (IN). No illnesses or injuries are reported in the source text. Healthcare providers and patients should stop using the affected units and contact Synthes (USA) Products LLC for further instructions.
The recalled product
- Product
- 5.0 mm Periprosthetic Locking Screw Self-tapping 12 mm Sterile; Catalog ID # 02.221.462S Indicated for fixation of various long bones.
- Manufacturer
- Synthes (USA) Products LLC
- Affected units
- 15
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 Number 5539094
Distribution
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