Allen Medical Bow Frame Model A-70800 — Class II medical device recall Z-0641-2018
Terminated recall by Allen Medical Systems, reported 2018-02-28, distributed nationwide. The base of the frame has the potential to crack when the patient is initially transferred to the Bow Frame.
| Recall number | Z-0641-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Allen Medical Systems, Acton, MA, United States |
| Recall initiated | 2017-10-06 |
| Classified | 2018-02-20 |
| Reported by FDA | 2018-02-28 |
| Terminated | 2019-04-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, BD, BR, CA, CH, CN, DE, DK, ES, FR, GB, GR, IT, JP, KR, KW, LB, MY, NL, TW |
| Quantity | 161 units |
| Reason classes | packaging |
| Serial numbers | A402596, A402597, A402598, A402599, A402604, A402605, A402606, A402607, A402608, A402609, A402610, A402611, A403277, A403278, A403279, A403280, A403281, A404960, A404961, A404962, A404963, A404964, A404965, A404966, A405472 and 89 more |
| Model numbers | A-70800 |
Product
Allen Medical Bow Frame Model A-70800. Surgical platform used to position patients for lumbar spine procedures.
Reason for recall
The base of the frame has the potential to crack when the patient is initially transferred to the Bow Frame.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0641-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.