Delta Cup Beater Positioner — Class II medical device recall Z-0068-2018
Completed recall by Limacorporate S.p.A, reported 2017-11-15. An internal analysis on complaints received indicated that the welding process may have been performed sub opt
| Recall number | Z-0068-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Limacorporate S.p.A, San Daniele del Friuli, N/A, Italy |
| Recall initiated | 2017-09-08 |
| Classified | 2017-11-06 |
| Reported by FDA | 2017-11-15 |
| Countries outside the US | AT, AU, BE, BR, CH, CZ, DE, ES, GB, IT, NZ, PL, RU, SI, SK, TR, ZA |
| Quantity | 20 units |
| Reason classes | potency, device malfunction |
| Lot numbers | 14AG243, 15AG00P, 15AG00Q, 15AG040, 15AG08Y, 15AG0HJ, 15AG0HN, 15AG0HQ, 15AG0UY, 15AG0UZ, 15AG0V0, 16AG02J |
| Model numbers | 9057.20.555 |
Product
Delta Cup Beater Positioner - Aligner, model # 9057.20.555 Used during implantation of the Delta Acetabular System
Reason for recall
An internal analysis on complaints received indicated that the welding process may have been performed sub optimally in the 12 lot # involved , leading to reduced mechanical strength of the device and possible breakage during impaction when the instrument is subjected to repeated multi-axial stresses.
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-0068-2018. 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.