Zimmer CoCr Femoral Heads Recalled for Potential Sterile Tray Compromise
Zimmer GmbH is recalling 1,908 CoCr Femoral Heads due to potential sterile tray compromise. Undetected breaches could lead to contamination and periprosthetic infection.
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 a periprosthetic infection is possible if contamination occurs, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Zimmer GmbH is recalling 1,908 units of CoCr Femoral Heads, a modular component used in total hip arthroplasty. The recall is due to a potential compromise of the inner sterile tray. The affected products were distributed domestically across 44 states and internationally to Canada and Japan.
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 a revision surgery. The source text does not report any specific illnesses or injuries associated with this recall.
Healthcare providers and patients should check their inventory and patient records for the specific item numbers and lot numbers listed in the recall notice. If a compromised tray is found, surgery may be delayed. For more information, contact the recalling firm or the FDA.
The recalled product
- Product
- CoCr Femoral Head - A modular head component is used in conjunction with a femoral stem component for replacement of the proximal femur in total hip arthroplasty.
- Manufacturer
- Zimmer Gmbh
- Affected units
- 1,908
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: 01.01012.384
- 01.01012.385
- 01.01012.386
- 01.01012.387
- 01.01012.388
- 01.01012.444
- 01.01012.445
- 01.01012.446
- 01.01012.447
- 01.01012.448 Lot #'s: 2551762
- 2542690
- 2542691
- 2543993
- 2544892
- 2544893
- 2551930
- 2551931
- 2557054
- 2558475
- 2559787
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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