Stryker Corporation, a medical device maker, has issued a voluntary recall of orthopedic implants because of potential damage to the device during the shipping process. The issue involves the packaging of the device that has been improperly designed.
About the Defective Orthopedic Implants
According to the Food and Drug Administration (FDA), the recall involves 16,992 orthopedic implants. The FDA has issued statements involving the integrity of the packaging which can greatly damage the device rendering it useless and even dangerous.
Medscape Medical News, reports that the Stryker Corporation has quarantined the product due to a hold that was put in place in February 2015.
The FDA has also stated that the case is a class 2 recall. This means that the use of or exposure of the violative product can cause temporary or medically reversible adverse health consequences.
Description of the Recalled Implants
All the following information was provided by Medscape Medical News:
- The recall includes five devices: the rHead lateral stem and Recon radial implant, both for replacement of the proximal end of the forearm's radius bone; the uHead ulnar implant and Sigmoid Notch radial plate, both for replacement of the distal radioulnar joint; and the Radio-Capitellum to improve elbow function.
- The products were manufactured in Mahwah, New Jersey, by Stryker Howmedica Osteonics and were distributed worldwide.
- Healthcare professionals are encouraged to report adverse events or adverse effects related to the use of these products to MedWatch, the FDA's safety information and adverse event reporting program.
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A recall has been issued for more than 400,000 Jeep SUVs amid complaints that a defect allows them to roll away even after drivers put their vehicles in park.
About the Jeep Grand Cherokee Recall
There have been 14 complaints from drivers reporting that vehicles have rolled away after being put in park. The instances have resulted in five crashes and three injuries.
According to KCCI, the Jeeps have electronic gear selectors, and when the shift lever is pulled the shifter does not move along a track.
The current recall covers 408,000 Grand Cherokees, model years 2014 and 2015.
NHTSA Launches Investigation
According to Reuters, the National Highway Traffic Safety Administration (NHTSA) has launched an investigation into the issue.
The investigation will attempt to determine the scope and frequency of the defect. They will then decide on if additional action needs to be taken.
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Allergan, a pharmaceutical company based out of New Jersey, has issued a voluntary recall of numerous eye ointments due to a number of consumer complaints.
List of Allergan Products Being Recalled
Allergan’s recall covers several specific products over a large number of lots. The products being recalled are:
- REFRESH Lacri-Lube 3.5g (NDC 0023-0312-04)
- REFRESH Lacri-Lube 7g (NDC 0023-0312-07)
- REFRESH P.M. 3.5g (NDC 0023-0240-04)
- REFRESH 3.5g (Professional Sample Pack) (NDC 0023-0240-04)
- FML (fluorometholone ophthalmic ointment) 0.1%, 3.5g (NDC 0023-0316-04)
- Blephamide (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) 10%/0.2%, 3.5g (NDC 0023-0313-04)
The specific lot numbers and expiration dates (ranging from April 2017 to March 2018) can be found in the FDA release, and can be found on the bottom flap of the carton with the safety seal and also on the crimp seal of the tube itself.
About the Recalled Ointments
According to a Medscape report, a number of customers have found a “small black particle attached to the product’s cap.” When the user attempts to unscrew the cap from the aluminum tube, the particle is at risk of detaching and making its way into the ointment.
Once it has made its way into the ointment, the consumer is at risk of accidentally applying the particle into the eyes.
There have been at least 23 complaints by consumers in relation to this recall, per the FDA release, including:
- Foreign body in the eye (12)
- Eye irritation (2)
- Ocular discomfort (2)
- Product contamination (2)
- Superficial injury of eye (2)
- Eye pain (1)
- Eye swelling (1)
- Vision blurred (1)
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