Trabecular Metal" Reverse Shoulder System
Class I - DangerousWhat Should You Do?
- Check if you have this product: 61025613, 61009830, 61038635, 61031385, 61021507, 61021506, 61016907, 61009834, 61006493, 61006492, 60999239, 60993837, 60993836, 60987295, 60982839, 60982838, 60970974, 60970973, 60950253, 60964425, 60946627, 60970946, 60964426, 60943695, 60940448, 60950251, 60946624, 60940449, 60927405, 60934492, 60900542, 60927406, 60919029, 60914617, 60919028, 60900543, 60893180, 60893181, 60906211, 60887745, 60887744, 60875337, 60875336, 60868040, 60873954, 60868041, 60867386, 60867385, 60856882, 60856880, 60855532, 60852815, 60855529, 60846158, 60846157, 60840619, 60834839, 60806512, 60824952, 60820211, 60814537, 60785523, 60795705, 60792083, 60761203, 60752933, 60781096, 60776583, 60765951, 60768804, 60757206, 60747093, 60741590, 60747092, 60741589, 60738183, 60727960, 60738184, 60730072, 60730073, 60723302, 60723277, 60718989, 60712568, 60683321, 60675599, 60669310, 60674468, 105533, 60605155, 105588, 60577323, 60580942, 60572796, 60564704, 60572798, 60568536, 60568535, 60578677, 60568468, 60568467, 60568466, 60564623, 60564639, 60564628, 60564641, 60564638, 60564636, 60568470, 60564642, 60564635, 60564625, 60564621, and 60564633.
- 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, Inc.
- Reason for Recall:
- As a result of complaints for disassociation of the TM Reverse Glenosphere from the Baseplate, Zimmer updated the related surgical technique and released a video to provide additional instructions to users on how to properly assemble the Glenosphere to the Baseplate.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Trabecular Metal" Reverse Shoulder System
Product Codes/Lot Numbers:
61025613, 61009830, 61038635, 61031385, 61021507, 61021506, 61016907, 61009834, 61006493, 61006492, 60999239, 60993837, 60993836, 60987295, 60982839, 60982838, 60970974, 60970973, 60950253, 60964425, 60946627, 60970946, 60964426, 60943695, 60940448, 60950251, 60946624, 60940449, 60927405, 60934492, 60900542, 60927406, 60919029, 60914617, 60919028, 60900543, 60893180, 60893181, 60906211, 60887745, 60887744, 60875337, 60875336, 60868040, 60873954, 60868041, 60867386, 60867385, 60856882, 60856880, 60855532, 60852815, 60855529, 60846158, 60846157, 60840619, 60834839, 60806512, 60824952, 60820211, 60814537, 60785523, 60795705, 60792083, 60761203, 60752933, 60781096, 60776583, 60765951, 60768804, 60757206, 60747093, 60741590, 60747092, 60741589, 60738183, 60727960, 60738184, 60730072, 60730073, 60723302, 60723277, 60718989, 60712568, 60683321, 60675599, 60669310, 60674468, 105533, 60605155, 105588, 60577323, 60580942, 60572796, 60564704, 60572798, 60568536, 60568535, 60578677, 60568468, 60568467, 60568466, 60564623, 60564639, 60564628, 60564641, 60564638, 60564636, 60568470, 60564642, 60564635, 60564625, 60564621, and 60564633.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1079-2014
Related Recalls
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.