Zimmer Manufacturing Recalls Sterile Hip and Trauma Implant Screws
Zimmer Manufacturing B.V. is recalling specific lots of sterile Hip and Trauma Implant Screws because a small hole may be present in the inner tray.
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 3/5 (High).
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 risk-of-harm product (medical device) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Zimmer Manufacturing B.V. is recalling specific lots of sterile Hip and Trauma Implant Screws. The affected products are M/DN Intramedullary Fixation 4.2 mm Diameter Cortical Screws with 3.5 mm Hex Heads, available in 45 mm and 70 mm lengths.
The recall is being issued because a small hole may be present in the inner tray of these specific lots. The source text does not specify the exact health risks associated with this defect or report any injuries or illnesses.
The recalled products were distributed worldwide, including in the United States, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador, Australia, India, Hong Kong, Chile, Germany, Italy, France, Spain, the UK, Sweden, and Canada. The affected lot numbers are 63295051 and 63293672. The source text does not provide specific instructions for consumers or healthcare providers on how to handle the recalled items.
The recalled product
- Product
- M/DN Intramedullary Fixation 4.2 mm Diameter Cortical Screw, 3.5 mm Hex Head, 45 mm Length 00225304542 M/DN Intramedullary Fixation 4.2 mm Diameter Cortical Screw, 3.5 mm Hex Head, 70 mm Length 00225307042
- Manufacturer
- Zimmer Manufacturing B.V.
- Hazard
- Affected units
- 219
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: 63295051 63293672
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
Same manufacturer · Zimmer Manufacturing B.V.
See all →- HighZimmer 3.5 mm Cortical Screws Recalled for Potential Sterility Compromise
FDA (Devices) · 2016-05-25
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- ModerateZimmer Recalls Sterile Hip and Trauma Implant Screws Due to Tray Defect
FDA (Devices) · 2016-05-25
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