Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 79205

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
October 06, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Allen Medical Systems

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

Allen Medical Bow Frame Model A-70800. Surgical platform used to position patients for lumbar spine procedures.

Z-0641-2018
Recall number
Z-0641-2018
Initiated
October 06, 2017
Classification
Class II
Status
Terminated
Recalling firm
Allen Medical Systems
Quantity
161 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The base of the frame has the potential to crack when the patient is initially transferred to the Bow Frame.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The base of the frame has the potential to crack when the patient is initially transferred to the Bow Frame.

Code information

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

Distribution pattern

Worldwide distribution. US Nationwide, Australia, Bangladesh, Brazil, Canada, China, Denmark, France, Germany, Greece, Italy, Japan, Korea, Kuwait, Lebanon, Malaysia, Netherlands, Spain, Switzerland, Taiwan, UAE, and UK.

device · product 2 of 2

Radiolucent Surgery Spine Frame (F70801). Surgical platform used to position patients for lumbar spine procedures.

Z-0642-2018
Recall number
Z-0642-2018
Initiated
October 06, 2017
Classification
Class II
Status
Terminated
Recalling firm
Allen Medical Systems
Quantity
161 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The base of the frame has the potential to crack when the patient is initially transferred to the Bow Frame.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The base of the frame has the potential to crack when the patient is initially transferred to the Bow Frame.

Code information

Serial Number: 533552 536025 536451 539585 539795 535272 536026 536452 539586 542764 535273 536027 536453 539587 544938 535274 536028 536454 539588 544939 535386 536029 536455 539589 544940 535387 536030 536456 539794 546200

Distribution pattern

Worldwide distribution. US Nationwide, Australia, Bangladesh, Brazil, Canada, China, Denmark, France, Germany, Greece, Italy, Japan, Korea, Kuwait, Lebanon, Malaysia, Netherlands, Spain, Switzerland, Taiwan, UAE, and UK.