U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Bone screw - Product Code HWC
Causa
The firm has been made aware that one lot of 6.5 cancellous bone screws 25mm was packaged and labeled as 25 mm in length when it maybe 20 mm in length.
Acción
The recalling firm sent notification letters and Product Accountability Forms via Fed Ex with return receipt on December 20, 2005. The notification letter described the problem, and asked customers to inventory and quarantine the affected product. Customers were told to return the affected product to Stryker. Contact Stryker at 1-201-831-5825 for assistance.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Resorbable calcium salt bone void filler device. - Product Code MQV
Causa
Exposure to temperature extremes -- product was not stored under controlled conditions and may have been temperature abused. exposure to temperature extremes could cause problems with device safety (e.G. risk of infection) or problems with device effectiveness (e.G. lower healing rates if the factors or collagen in the device were affected by the temperature extremes).
Acción
Three units were picked up from the consignee on or about 5/05/08. The implanting physician was verbally advised of the problem with the fourth unit. If you have any questions contact Michigan Orthopaedic Products, Inc. at (616) 249-8937.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Prosthesis - Product Code JDI
Causa
Product not manufactured to specifications; modular femoral necks found to contain 24 scallops, instead of the standard 12.
Acción
Firm notified sales agents of recall on 05/08/08 via an Urgent: Medical Device Recall letter. Sales agents asked to immediately examine their inventory and quarantine product subject to recall. Agents are asked to notify their customers if they had further distributed the product. All product must be returned to Encore along with the response form.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Bone Fixation - Product Code HWC
Causa
Product sterility may be compromised.
Acción
The firm issued four separate Urgent Notification: Product Removal were issued by the firm on 2-14-2008, 2-20-2008, 2-26-2008, and 3-25-2008 for the issue of poorly sealed sterile pouches. The notifications were reportedly sent by either FAX or e-mail. The firm explained the issue and requested customers to return the specified products. On 7/16/08, the firm issued a second recall notification to their customers. This letter informed the customer of the recall, listed the products affected, stated the reason for the recall, tells customers, "return existing inventories of the recalled products to Acumed... If you further distributed this product, please notify those customers/consignees of this recall. This recall is to be extended to the user level." The letter includes an effectiveness form to be filled out by the customer and returned to Acumed.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
This recall was initiated after internal engineering testing of the conical seat design pedicle screws of sizes 5, 6 and 7 showed a potential of partial displacement of screw shank when used in combination with the single piece locking nuts. this partial displacement of the screw shank could finally lead to total separation and failure of the construct.
Acción
Allez Spine informed all parties who were in possession of the affected pedicle screws at the time of the initiation of this field action by phone on 11/08/2007 and requested the return of their inventory.
All customers and consignees were contacted by the firm.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
This recall was initiated after internal engineering testing of the conical seat design pedicle screws of sizes 5, 6 and 7 showed a potential of partial displacement of screw shank when used in combination with the single piece locking nuts. this partial displacement of the screw shank could finally lead to total separation and failure of the construct.
Acción
Allez Spine informed all parties who were in possession of the affected pedicle screws at the time of the initiation of this field action by phone on 11/08/2007 and requested the return of their inventory.
All customers and consignees were contacted by the firm.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
This recall was initiated after internal engineering testing of the conical seat design pedicle screws of sizes 5, 6 and 7 showed a potential of partial displacement of screw shank when used in combination with the single piece locking nuts. this partial displacement of the screw shank could finally lead to total separation and failure of the construct.
Acción
Allez Spine informed all parties who were in possession of the affected pedicle screws at the time of the initiation of this field action by phone on 11/08/2007 and requested the return of their inventory.
All customers and consignees were contacted by the firm.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
This recall was initiated after internal engineering testing of the conical seat design pedicle screws of sizes 5, 6 and 7 showed a potential of partial displacement of screw shank when used in combination with the single piece locking nuts. this partial displacement of the screw shank could finally lead to total separation and failure of the construct.
Acción
Allez Spine informed all parties who were in possession of the affected pedicle screws at the time of the initiation of this field action by phone on 11/08/2007 and requested the return of their inventory.
All customers and consignees were contacted by the firm.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
This recall was initiated after internal engineering testing of the conical seat design pedicle screws of sizes 5, 6 and 7 showed a potential of partial displacement of screw shank when used in combination with the single piece locking nuts. this partial displacement of the screw shank could finally lead to total separation and failure of the construct.
Acción
Allez Spine informed all parties who were in possession of the affected pedicle screws at the time of the initiation of this field action by phone on 11/08/2007 and requested the return of their inventory.
All customers and consignees were contacted by the firm.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
This recall was initiated after internal engineering testing of the conical seat design pedicle screws of sizes 5, 6 and 7 showed a potential of partial displacement of screw shank when used in combination with the single piece locking nuts. this partial displacement of the screw shank could finally lead to total separation and failure of the construct.
Acción
Allez Spine informed all parties who were in possession of the affected pedicle screws at the time of the initiation of this field action by phone on 11/08/2007 and requested the return of their inventory.
All customers and consignees were contacted by the firm.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
This recall was initiated after internal engineering testing of the conical seat design pedicle screws of sizes 5, 6 and 7 showed a potential of partial displacement of screw shank when used in combination with the single piece locking nuts. this partial displacement of the screw shank could finally lead to total separation and failure of the construct.
Acción
Allez Spine informed all parties who were in possession of the affected pedicle screws at the time of the initiation of this field action by phone on 11/08/2007 and requested the return of their inventory.
All customers and consignees were contacted by the firm.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
This recall was initiated after internal engineering testing of the conical seat design pedicle screws of sizes 5, 6 and 7 showed a potential of partial displacement of screw shank when used in combination with the single piece locking nuts. this partial displacement of the screw shank could finally lead to total separation and failure of the construct.
Acción
Allez Spine informed all parties who were in possession of the affected pedicle screws at the time of the initiation of this field action by phone on 11/08/2007 and requested the return of their inventory.
All customers and consignees were contacted by the firm.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
This recall was initiated after internal engineering testing of the conical seat design pedicle screws of sizes 5, 6 and 7 showed a potential of partial displacement of screw shank when used in combination with the single piece locking nuts. this partial displacement of the screw shank could finally lead to total separation and failure of the construct.
Acción
Allez Spine informed all parties who were in possession of the affected pedicle screws at the time of the initiation of this field action by phone on 11/08/2007 and requested the return of their inventory.
All customers and consignees were contacted by the firm.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
This recall was initiated after internal engineering testing of the conical seat design pedicle screws of sizes 5, 6 and 7 showed a potential of partial displacement of screw shank when used in combination with the single piece locking nuts. this partial displacement of the screw shank could finally lead to total separation and failure of the construct.
Acción
Allez Spine informed all parties who were in possession of the affected pedicle screws at the time of the initiation of this field action by phone on 11/08/2007 and requested the return of their inventory.
All customers and consignees were contacted by the firm.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
This recall was initiated after internal engineering testing of the conical seat design pedicle screws of sizes 5, 6 and 7 showed a potential of partial displacement of screw shank when used in combination with the single piece locking nuts. this partial displacement of the screw shank could finally lead to total separation and failure of the construct.
Acción
Allez Spine informed all parties who were in possession of the affected pedicle screws at the time of the initiation of this field action by phone on 11/08/2007 and requested the return of their inventory.
All customers and consignees were contacted by the firm.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Bone Fixation - Product Code HWC
Causa
Product sterility may be compromised.
Acción
The firm issued four separate Urgent Notification: Product Removal were issued by the firm on 2-14-2008, 2-20-2008, 2-26-2008, and 3-25-2008 for the issue of poorly sealed sterile pouches. The notifications were reportedly sent by either FAX or e-mail. The firm explained the issue and requested customers to return the specified products. On 7/16/08, the firm issued a second recall notification to their customers. This letter informed the customer of the recall, listed the products affected, stated the reason for the recall, tells customers, "return existing inventories of the recalled products to Acumed... If you further distributed this product, please notify those customers/consignees of this recall. This recall is to be extended to the user level." The letter includes an effectiveness form to be filled out by the customer and returned to Acumed.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Bone Fixation - Product Code HWC
Causa
Product sterility may be compromised.
Acción
The firm issued four separate Urgent Notification: Product Removal were issued by the firm on 2-14-2008, 2-20-2008, 2-26-2008, and 3-25-2008 for the issue of poorly sealed sterile pouches. The notifications were reportedly sent by either FAX or e-mail. The firm explained the issue and requested customers to return the specified products. On 7/16/08, the firm issued a second recall notification to their customers. This letter informed the customer of the recall, listed the products affected, stated the reason for the recall, tells customers, "return existing inventories of the recalled products to Acumed... If you further distributed this product, please notify those customers/consignees of this recall. This recall is to be extended to the user level." The letter includes an effectiveness form to be filled out by the customer and returned to Acumed.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Bone Fixation - Product Code HWC
Causa
Product sterility may be compromised.
Acción
The firm issued four separate Urgent Notification: Product Removal were issued by the firm on 2-14-2008, 2-20-2008, 2-26-2008, and 3-25-2008 for the issue of poorly sealed sterile pouches. The notifications were reportedly sent by either FAX or e-mail. The firm explained the issue and requested customers to return the specified products. On 7/16/08, the firm issued a second recall notification to their customers. This letter informed the customer of the recall, listed the products affected, stated the reason for the recall, tells customers, "return existing inventories of the recalled products to Acumed... If you further distributed this product, please notify those customers/consignees of this recall. This recall is to be extended to the user level." The letter includes an effectiveness form to be filled out by the customer and returned to Acumed.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Bone Fixation - Product Code HWC
Causa
Product sterility may be compromised.
Acción
The firm issued four separate Urgent Notification: Product Removal were issued by the firm on 2-14-2008, 2-20-2008, 2-26-2008, and 3-25-2008 for the issue of poorly sealed sterile pouches. The notifications were reportedly sent by either FAX or e-mail. The firm explained the issue and requested customers to return the specified products. On 7/16/08, the firm issued a second recall notification to their customers. This letter informed the customer of the recall, listed the products affected, stated the reason for the recall, tells customers, "return existing inventories of the recalled products to Acumed... If you further distributed this product, please notify those customers/consignees of this recall. This recall is to be extended to the user level." The letter includes an effectiveness form to be filled out by the customer and returned to Acumed.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Bone Fixation - Product Code HWC
Causa
Product sterility may be compromised.
Acción
The firm issued four separate Urgent Notification: Product Removal were issued by the firm on 2-14-2008, 2-20-2008, 2-26-2008, and 3-25-2008 for the issue of poorly sealed sterile pouches. The notifications were reportedly sent by either FAX or e-mail. The firm explained the issue and requested customers to return the specified products. On 7/16/08, the firm issued a second recall notification to their customers. This letter informed the customer of the recall, listed the products affected, stated the reason for the recall, tells customers, "return existing inventories of the recalled products to Acumed... If you further distributed this product, please notify those customers/consignees of this recall. This recall is to be extended to the user level." The letter includes an effectiveness form to be filled out by the customer and returned to Acumed.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Bone Fixation - Product Code HWC
Causa
Product sterility may be compromised.
Acción
The firm issued four separate Urgent Notification: Product Removal were issued by the firm on 2-14-2008, 2-20-2008, 2-26-2008, and 3-25-2008 for the issue of poorly sealed sterile pouches. The notifications were reportedly sent by either FAX or e-mail. The firm explained the issue and requested customers to return the specified products. On 7/16/08, the firm issued a second recall notification to their customers. This letter informed the customer of the recall, listed the products affected, stated the reason for the recall, tells customers, "return existing inventories of the recalled products to Acumed... If you further distributed this product, please notify those customers/consignees of this recall. This recall is to be extended to the user level." The letter includes an effectiveness form to be filled out by the customer and returned to Acumed.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Bone Fixation - Product Code HWC
Causa
Product sterility may be compromised.
Acción
The firm issued four separate Urgent Notification: Product Removal were issued by the firm on 2-14-2008, 2-20-2008, 2-26-2008, and 3-25-2008 for the issue of poorly sealed sterile pouches. The notifications were reportedly sent by either FAX or e-mail. The firm explained the issue and requested customers to return the specified products. On 7/16/08, the firm issued a second recall notification to their customers. This letter informed the customer of the recall, listed the products affected, stated the reason for the recall, tells customers, "return existing inventories of the recalled products to Acumed... If you further distributed this product, please notify those customers/consignees of this recall. This recall is to be extended to the user level." The letter includes an effectiveness form to be filled out by the customer and returned to Acumed.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Bone Fixation - Product Code HWC
Causa
Product sterility may be compromised.
Acción
The firm issued four separate Urgent Notification: Product Removal were issued by the firm on 2-14-2008, 2-20-2008, 2-26-2008, and 3-25-2008 for the issue of poorly sealed sterile pouches. The notifications were reportedly sent by either FAX or e-mail. The firm explained the issue and requested customers to return the specified products. On 7/16/08, the firm issued a second recall notification to their customers. This letter informed the customer of the recall, listed the products affected, stated the reason for the recall, tells customers, "return existing inventories of the recalled products to Acumed... If you further distributed this product, please notify those customers/consignees of this recall. This recall is to be extended to the user level." The letter includes an effectiveness form to be filled out by the customer and returned to Acumed.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Bone Fixation - Product Code HWC
Causa
Product sterility may be compromised.
Acción
The firm issued four separate Urgent Notification: Product Removal were issued by the firm on 2-14-2008, 2-20-2008, 2-26-2008, and 3-25-2008 for the issue of poorly sealed sterile pouches. The notifications were reportedly sent by either FAX or e-mail. The firm explained the issue and requested customers to return the specified products. On 7/16/08, the firm issued a second recall notification to their customers. This letter informed the customer of the recall, listed the products affected, stated the reason for the recall, tells customers, "return existing inventories of the recalled products to Acumed... If you further distributed this product, please notify those customers/consignees of this recall. This recall is to be extended to the user level." The letter includes an effectiveness form to be filled out by the customer and returned to Acumed.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Bone Fixation - Product Code HWC
Causa
Product sterility may be compromised.
Acción
The firm issued four separate Urgent Notification: Product Removal were issued by the firm on 2-14-2008, 2-20-2008, 2-26-2008, and 3-25-2008 for the issue of poorly sealed sterile pouches. The notifications were reportedly sent by either FAX or e-mail. The firm explained the issue and requested customers to return the specified products. On 7/16/08, the firm issued a second recall notification to their customers. This letter informed the customer of the recall, listed the products affected, stated the reason for the recall, tells customers, "return existing inventories of the recalled products to Acumed... If you further distributed this product, please notify those customers/consignees of this recall. This recall is to be extended to the user level." The letter includes an effectiveness form to be filled out by the customer and returned to Acumed.