Ossur Americas Recalls
Showing 1-4 of 4 recalls
OSSUR VARIFLEX SUBA JUNIOR foot and ankle external prosthesis, sized for children and adolescents.
Due to receiving complaints related to broken (cracked) prosthetic foot with failures occurring in situations where sudden high impact twisting or bending is applied to the foot.
On 05/30/2022, Ossur sent an "URGENT FIELD SAFETY NOTICE" via email informing customers that Ossur received customer complaints related to broken Vari-Flex Junior feet with failures occurring in situations where sudden high impact twisting or bending is applied to the foot. Such circumstances can happen in sports activities, including for example football/soccer. To ensure compliance and user safety the Instructions for Use, IFU 1121_001 for Vari-Flex Junior, have been updated from version 6 to version 7 to include the additional information required. The specific updates are outlined/highlighted in yellow. Action require of customers are: 1. Please monitor and review the activities of those patients that have already been fitted with the Vari-Flex Junior. If the Vari-Flex Junior is not suitable, another type of device or an additional foot should be considered, depending on the patients needs. 2. Please ensure the updated Instructions for Use and this notice are distributed to the necessary persons within the organization. A copy of the updated instructions accompanies this notice. 3. Please pass this notice to those who need to be aware within your organization or to any organization where Vari-Flex Junior devices have been transferred. 4. Please retain this letter in a prominent position for one month. 5. If you have further distributed this product, please identify your customers, and notify them at once of this Field Safety Notice. We recommend that you include a copy of this notice. 6. Reply to the email/mail that you received confirming receipt of this notice and the updated instructions for use, as we require this information to reconcile this process. For questions, UNITED STATES can contact Ossur Americas at 1-800-233-6263
Miami J Select Collar, Item: MJS-101, and Miami J Select Collar Set, Item: MJSR-101 Instructions for Use
Instructions for use were updated to include additional information to facilitate the selection and use of the collar device.
On 11/09/21, Field Safety Notices and updated Instructions for Use, Rev. 6 2021, were emailed to customers. Customers were asked to take the following actions: 1.Please ensure the updated Instructions for Use are distributed to the necessary persons within the organization and that they are adhered to when selecting and using the Miami J Select device. A copy of the updated instructions accompanies this notice. 2.Please pass this notice to those who need to be aware within your organization or to any organization where the listed devices have been transferred. 3.Please retain this letter in a prominent position for one month. 4.If you have further distributed this product, please identify your customers, and notify them at once of this Field Safety Notice. We recommend that you include a copy of this notice. 5.Reply to the email that you received confirming receipt of this notice and the updated instructions for use, even if your facility is no longer in possession of affected devices. Customers are encouraged to contact customer service for further information and assistance: U.S. 1-800-233-6263
OSSUR MIAMI J SELECT COLLAR - Product Usage: is intended to provide gross immobilization to the cervical spine. REF: MJS-101; MJSR-101
Due to insufficient column strength of the racks for all load conditions, racks associated with height adjustment functionality have been observed deforming, which may lead to increased range of motion in the cervical spine.
On 06/01/2021, the Recalling Firm emailed or called its customers and provided an "URGENT MEDICAL DEVICE RECALL" letter informing them that it had identified that cervical collars may deform under certain conditions, possibly leading to reduced immobilization of the cervical spine. The likelihood of deformation is higher when in use at higher height configurations. Further, the risk of deformation increases with the number of days the device is worn. Customers are instructed to: -Examine their inventory, quarantine products subject to the recall, and return the Customer Acknowledgement Form to the email address listed on the form. A return authorization will then be provided to return the product to the Recalling Firm. Additional actions to take: 1. Pass this notice to those who need to be aware within the customer's organization or to any organization where the potentially affected devices has been transferred. 2. Maintain awareness on this notice for an appropriate period. 3. If the affected products have been further distributed, identify the customers, and notify them at once of this recall. The Recalling Firm recommends including a copy of this recall letter. 4. The Recalling Firm recommends healthcare professionals perform a detailed inspection of the device to verify lot number, and to ensure proper fit and structural stability for any patients current wearing impacted product. 5. If any customers are currently wearing a product, the packaging label should be inspected for the lot number (Note: The number inside the collar is not the lot number; that is the device serial number). " If the lot number is outside of the affected range, no actions need to be taken. " If the lot number is inside the affected range, healthcare professionals are advised to assess whether a removal and replacement of impacted product currently in use is warranted on a case-by-case basis. " If the packaging label/lot number is not available, healthcare professionals a
Ossur Skull Pin, Sterile Titanium Pin, Part/Description: 516TS/ Skull Pin 2-1/4in TI Sterl 1PK; 516V2S/ Skull Pin 3in TI Sterl 1PK; 520TS/ Skull Pin 2-1/4in TI Sterl 5PK; 520V2S/ Skull Pin 3in TI Sterl 5 PK
Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm MR conditional parameters. In addition, the second line description on the titanium pin label mistakenly lists ceramic tip. The second line description should state titanium pin.
On 06/21/2018, Urgent Field Safety Notices were mailed to customers via UPS Next-Day Air requiring a signature of acceptance from the customer. Customers were advised the following: 1. Please pass this notice to those who need to be aware within your organization or to any department areas where the potentially affected devices will be used or transferred. 2. Maintain awareness on this notice for an appropriate period. 3. If you would like to have the product replaced please contact your customer service or sales representative and new product will be provided. Customers can exchange the affected product, if they desire to do so. Customers were asked to distribute the notices to those who need to be aware within their organization or to any department areas where the potentially affected devices were used or transferred. On 01/14/2019, Urgent Medical Device Recall letters were sent via express mail requiring a signature of acceptance from the customer. Customers were advised: Please examine your inventory, quarantine products subject to the recall and contact customer service for a return authorization to return the product. In addition: 1. Please confirm receipt of this recall notice by calling customer service (800-233-6263) or visit https://safetyalert.ossur.com 2. Please pass this notice to those who need to be aware within your organization and to any department areas where the potentially affected devices will be used or transferred (e.g. MR Imaging, Surgical, Emergency, Material Management, Patient) 3. Maintain awareness on this notice for an appropriate period. 4. If you have further distributed this product, please identify your customers and notify them at once of this product alert. We recommend that you include a copy of this product recall. 5. If any of your patients is currently wearing the product, necessary arrangements should be made to ensure the patient is not placed in MR Imaging.