Allen Medical Bow Frame Model A-70800. Surgical platform used to position patients for lumbar spine procedures.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Serial Number: A402596 A404960 A407142 A408656 A411816 A415114 A416956 A402597 A404961 A407143 A408657 A411817 A415115 A416957 A402598 A404962 A407144 A408658 A411818 A415116 A416958 A402599 A404963 A407145 A409320 A411819 A415117 A416959 A402604 A404964 A407146 A409321 A411820 A415726 A416960 A402605 A404965 A407460 A409322 A412539 A415727 A416961 A402606 A404966 A407147 A409323 A412540 A415728 A417547 A402607 A405472 A407461 A409335 A412541 A415729 A417548 A402608 A405473 A407885 A409336 A412542 A416163 A417549 A402609 A405474 A407886 A410068 A412543 A416164 A417550 A402610 A405475 A407887 A410069 A412544 A416165 A417919 A402611 A405476 A407888 A410070 A412545 A416166 A543137 A403277 A405477 A407889 A410071 A412546 A416167 A403278 A405478 A407890 A410072 A413529 A416168 A403279 A405479 A407891 A410073 A413530 A416169 A403280 A405787 A407892 A410074 A413531 A416170 A403281 A405788 A407893 A410075 A413532 A416270
- 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:
- Allen Medical Systems
- Reason for Recall:
- The base of the frame has the potential to crack when the patient is initially transferred to the Bow Frame.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Allen Medical Bow Frame Model A-70800. Surgical platform used to position patients for lumbar spine procedures.
Product Codes/Lot Numbers:
Serial Number: A402596 A404960 A407142 A408656 A411816 A415114 A416956 A402597 A404961 A407143 A408657 A411817 A415115 A416957 A402598 A404962 A407144 A408658 A411818 A415116 A416958 A402599 A404963 A407145 A409320 A411819 A415117 A416959 A402604 A404964 A407146 A409321 A411820 A415726 A416960 A402605 A404965 A407460 A409322 A412539 A415727 A416961 A402606 A404966 A407147 A409323 A412540 A415728 A417547 A402607 A405472 A407461 A409335 A412541 A415729 A417548 A402608 A405473 A407885 A409336 A412542 A416163 A417549 A402609 A405474 A407886 A410068 A412543 A416164 A417550 A402610 A405475 A407887 A410069 A412544 A416165 A417919 A402611 A405476 A407888 A410070 A412545 A416166 A543137 A403277 A405477 A407889 A410071 A412546 A416167 A403278 A405478 A407890 A410072 A413529 A416168 A403279 A405479 A407891 A410073 A413530 A416169 A403280 A405787 A407892 A410074 A413531 A416170 A403281 A405788 A407893 A410075 A413532 A416270
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0641-2018
Related Recalls
The recalling firm has become aware that the rail section clamps used to attach the leg support of the device may fail during use, which could result in critical harm to the patient.
Radiolucent Surgery Spine Frame (F70801). Surgical platform used to position patients for lumbar spine procedures.
Allen Medical Systems
The base of the frame has the potential to crack when the patient is initially transferred to the Bow Frame.
During use, there is a potential scenario which could allow the fastening screws attaching covers to come loose and potentially land in the sterile field causing a delay in surgery.