Zimmer CoCr Femoral Heads Recalled for Potential Sterile Tray Compromise
Zimmer GmbH is recalling 6,109 CoCr femoral heads due to potential sterile tray compromise, which could lead to periprosthetic infection if undetected.
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 periprosthetic infection, a serious health consequence, but the source text does not report any actual illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Zimmer GmbH is recalling 6,109 units of CoCr Femoral Heads used for hip arthroplasty. The recall is due to a potential compromise of the inner sterile tray. The affected devices are indicated for noncemented use in skeletally mature individuals undergoing primary surgery for noninflammatory degenerative joint disease.
The hazard associated with this recall is that if a compromised tray is detected, it may result in a delay in surgery. If an undetected breach occurs in both the inner and outer trays and contamination is present, a periprosthetic infection is possible, which could lead to revision surgery.
The recalled products were distributed domestically to 48 states and internationally to Canada and Japan. The specific item numbers and lot numbers are listed in the structured product information. Consumers and healthcare providers should contact Zimmer GmbH for further instructions on how to handle the affected devices.
The recalled product
- Product
- CoCr Femoral Head - indicated for hip arthroplasty for noncemented use in skeletally mature invididuals undergoing primary surgery for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease
- Manufacturer
- Zimmer Gmbh
- Affected units
- 6,109
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 (20)
- Item numbers: 7210-22-000
- 7210-22-350
- 7210-22-800
- 7210-26-000
- 7210-26-035
- 7210-26-350
- 7210-26-800
- 7210-28-000
- 7210-28-004
- 7210-28-400
- 7210-28-800
- 7210-32-000
- 7210-32-004
- 7210-32-400
- 7210-32-800. Lot #'s: 61487412
- 61516918
- 61525215
- 61533617
- 61582735
- 61417397
Distribution
Part of a larger recall action
This product is one of 5 recalled by Zimmer Gmbh 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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Similar recalls
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