PlainRecordsFDA · Medical device recall
ATLANTIS Element Express Kit… and 5 more products
- Date posted by the FDA
- Jan. 28, 2005
- Status
- Terminated
- Filed by
- Warsaw Orthopedic, Inc.
- Distribution pattern
- Belgium, Croatia, Denmark, Finland, France, Hong Kong, India, Jamaica, Netherlands, Nicaragua, Portugal, Romania and Russia.
6 products in this recall
ATLANTIS Element Express Kit…
- Product
- ATLANTIS Element Express Kit; a sterile kit for cervical spine surgery which includes hex-head screwdriver, bone plate and 4 bone screws; catalog number 786-123.
- Reason
- The hex head of the screw driver may be too large to fit the screw heads of the bone screws included in the kit.
- Quantity
- 119
- Codes and lots
- Lots 796010 and 634540.
- Recall started
- Jan. 4, 2005
- Device type
- Screw, Fixation, Bone
- Root cause (FDA)
- Other
- What the company told customers
- Consignees were notified, via a recall letter dated 12/27/04 and issued on 1/4/05, to return the product. Competent Authorities were notified via letter dated 1/12/05.
- Recall number
- Z-0446-05
ATLANTIS Element Express Kit…
- Product
- ATLANTIS Element Express Kit; a sterile kit for cervical spine surgery which includes hex-head screwdriver, bone plate and 4 bone screws; catalog number 786-125.
- Reason
- The hex head of the screw driver may be too large to fit the screw heads of the bone screws included in the kit.
- Quantity
- 142
- Codes and lots
- Lots 634550, 796050 and 796040.
- Recall started
- Jan. 4, 2005
- Device type
- Screw, Fixation, Bone
- Root cause (FDA)
- Other
- What the company told customers
- Consignees were notified, via a recall letter dated 12/27/04 and issued on 1/4/05, to return the product. Competent Authorities were notified via letter dated 1/12/05.
- Recall number
- Z-0447-05
ATLANTIS Element Express Kit…
- Product
- ATLANTIS Element Express Kit; a sterile kit for cervical spine surgery which includes hex-head screwdriver, bone plate and 4 bone screws; catalog number 786-127.
- Reason
- The hex head of the screw driver may be too large to fit the screw heads iof the bone screws included in the kit.
- Quantity
- 122
- Codes and lots
- Lots 634560 and 802080.
- Recall started
- Jan. 4, 2005
- Device type
- Screw, Fixation, Bone
- Root cause (FDA)
- Other
- What the company told customers
- Consignees were notified, via a recall letter dated 12/27/04 and issued on 1/4/05, to return the product. Competent Authorities were notified via letter dated 1/12/05.
- Recall number
- Z-0448-05
ATLANTIS Element Express Kit…
- Product
- ATLANTIS Element Express Kit; a sterile kit for cervical spine surgery which includes hex-head screwdriver, bone plate and 4 bone screws; catalog number 786-140.
- Reason
- The hex head of the screw driver may be too large to fit the screw heads of the bone screws included in the kit.
- Quantity
- 121
- Codes and lots
- Lots 634570 and 802070.
- Recall started
- Jan. 4, 2005
- Device type
- Screw, Fixation, Bone
- Root cause (FDA)
- Other
- What the company told customers
- Consignees were notified, via a recall letter dated 12/27/04 and issued on 1/4/05, to return the product. Competent Authorities were notified via letter dated 1/12/05.
- Recall number
- Z-0449-05
ATLANTIS Element Express Kit…
- Product
- ATLANTIS Element Express Kit; a sterile kit for cervical spine surgery which includes hex-head screwdriver, bone plate and 4 bone screws; catalog number 786-142.
- Reason
- The hex head of the screw driver may be too large to fit the screw heads of the bone screws included in the kit.
- Quantity
- 214
- Codes and lots
- Lots 634580, 796070, 857390, 796030, 802090 and 878300.
- Recall started
- Jan. 4, 2005
- Device type
- Screw, Fixation, Bone
- Root cause (FDA)
- Other
- What the company told customers
- Consignees were notified, via a recall letter dated 12/27/04 and issued on 1/4/05, to return the product. Competent Authorities were notified via letter dated 1/12/05.
- Recall number
- Z-0450-05
ATLANTIS Element Express Kit…
- Product
- ATLANTIS Element Express Kit; a sterile kit for cervical spine surgery which includes hex-head screwdriver, bone plate and 4 bone screws; catalog number 786-145.
- Reason
- The hex head of the screw driver may be too large to fit the screw heads of the bone screws included in the kit.
- Quantity
- 182
- Codes and lots
- Lots 634590, 671730, 789870, 789860, 796020, 789880 and 744910.
- Recall started
- Jan. 4, 2005
- Device type
- Screw, Fixation, Bone
- Root cause (FDA)
- Other
- What the company told customers
- Consignees were notified, via a recall letter dated 12/27/04 and issued on 1/4/05, to return the product. Competent Authorities were notified via letter dated 1/12/05.
- Recall number
- Z-0451-05
What should I do? How serious is a recall? Classes and warnings explained
Source: FDA · Medical device enforcement reports, recall numbers Z-0446-05, Z-0447-05, Z-0448-05, Z-0449-05, Z-0450-05, Z-0451-05. The agency record governs; check it and the company before acting.