Zimmer Herbert Cannulated Bone Screw Recall for Sterility Concerns
Zimmer Manufacturing B.V. is recalling specific lots of Herbert Cannulated Bone Screws because a small hole may be present in the inner tray, potentially compromising sterility.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a potential sterility breach in a medical device, which poses a risk of infection (harm) but the source text does not report any specific illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Zimmer Manufacturing B.V. is recalling 90 units of the Herbert Cannulated Bone Screw System, specifically the 6.5 mm diameter screws in 45 mm, 75 mm, and 90 mm lengths. The recall affects specific lots (63303808, 63292589, 63292588) of sterile Hip and Trauma Implant Screws.
The recall was initiated because a small hole may be present in the inner tray of these specific lots. This defect could potentially compromise the sterile integrity of the packaging. The affected products were distributed worldwide, including in the US, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador, Australia, India, Hong Kong, Chile, Germany, Italy, France, Spain, UK, Sweden, and Canada.
Healthcare providers and facilities should check their inventory for the affected lot numbers and stop using these specific screws. Consumers who have had these implants should contact their healthcare provider for guidance.
The recalled product
- Product
- Herbert Cannulated Bone Screw System, Bone Screw, 6.5 mm Dia., 45 mm Length 47115504507 Herbert Cannulated Bone Screw System, Bone Screw, 6.5 mm Dia., 75 mm Length 47115507507 Herbert Cannulated Bone Screw System, Bone Screw, 6.5 mm Dia., 90 mm Length 47115509007
- Manufacturer
- Zimmer Manufacturing B.V.
- Affected units
- 90
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)
- LOTS: 63303808 63292589 63292588
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 12 recalled by Zimmer Manufacturing B.V. 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.
See all 12 products in this recall →Related recalls
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