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
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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, 61487413, 61417398, 61393996, 61393997, 61417401, 61417402, 61487414, 61487415, 61487416, 61487417, 61487418, 61487420, 61487422, 61487423, 61495211, 61495212, 61500247, 61516884, 61516885, 61516886, 61516888, 61525212, 61525213, 61533606, 61533607, 61533608, 61538022, 61538024, 61538026, 61554502, 61565073, 61565079, 61565081, 61565082, 61582736, 61417403, 61487424, 61487425, 61487426, 61495218, 61516903, 61516904, 61525214, 61533612, 61565084, 61565085, 61577701, 61582737, 61417399, 61487427, 61487428, 61487429, 61495210, 61516881, 61516882, 61533605, 61538021, 61543660, 61565071, 61565072, 61487443, 61565088, 61487447, 61487450, 61500252, 61525210, 61533616, 61565091, 61565104, 61582738, 61487453, 61500245, 61525209, 61565102, 61394048, 61487455, 61500250, 61538042, 61577704, 61487456, 61565101, 61382197, 61394027, 61394029, 61417404, 61417405, 61487571, 61487572, 61487573, 61487574, 61487575, 61487576, 61487577, 61495217, 61516893, 61516894, 61516896, 61516897, 61516898, 61525224, 61525225, 61525226, 61533610, 61538041, 61543661, 61565106, 61565112, 61565119, 61565125, 61382207, 61393990, 61417407, 61487578, 61487579, 61487580, 61487581, 61495237, 61516921, 61516922, 61525230, 61538057, 61543828, 61565116, 61565124, 61582745, 61394050, 61417406, 61487582, 61487583, 61487584, 61500251, 61516927, 61525227, 61525228, 61565109, 61565121, 61402292, 61487585, 61516917, 61525229, 61565122
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Zimmer Gmbh
- Reason for Recall:
- Potential compromise of the inner sterile tray. If a compromised tray is detected, a delay in surgery may result. If undetected breach in both the inner and outer trays were to occur, and there is contamination present, a periprosthetic infection is possible, which could lead to revision.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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
Product Codes/Lot Numbers:
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, 61487413, 61417398, 61393996, 61393997, 61417401, 61417402, 61487414, 61487415, 61487416, 61487417, 61487418, 61487420, 61487422, 61487423, 61495211, 61495212, 61500247, 61516884, 61516885, 61516886, 61516888, 61525212, 61525213, 61533606, 61533607, 61533608, 61538022, 61538024, 61538026, 61554502, 61565073, 61565079, 61565081, 61565082, 61582736, 61417403, 61487424, 61487425, 61487426, 61495218, 61516903, 61516904, 61525214, 61533612, 61565084, 61565085, 61577701, 61582737, 61417399, 61487427, 61487428, 61487429, 61495210, 61516881, 61516882, 61533605, 61538021, 61543660, 61565071, 61565072, 61487443, 61565088, 61487447, 61487450, 61500252, 61525210, 61533616, 61565091, 61565104, 61582738, 61487453, 61500245, 61525209, 61565102, 61394048, 61487455, 61500250, 61538042, 61577704, 61487456, 61565101, 61382197, 61394027, 61394029, 61417404, 61417405, 61487571, 61487572, 61487573, 61487574, 61487575, 61487576, 61487577, 61495217, 61516893, 61516894, 61516896, 61516897, 61516898, 61525224, 61525225, 61525226, 61533610, 61538041, 61543661, 61565106, 61565112, 61565119, 61565125, 61382207, 61393990, 61417407, 61487578, 61487579, 61487580, 61487581, 61495237, 61516921, 61516922, 61525230, 61538057, 61543828, 61565116, 61565124, 61582745, 61394050, 61417406, 61487582, 61487583, 61487584, 61500251, 61516927, 61525227, 61525228, 61565109, 61565121, 61402292, 61487585, 61516917, 61525229, 61565122
Distribution:
Nationwide distribution
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1135-2105
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