FDA Medical Device Recalls (openFDA)
Limacorporate S.p.A: Delta Cup Beater Positioner - Aligner, model # 9057.20.555 Used during implantation of the Delta Acetabular System
- Recall number
- Z-0068-2018
- Recalling firm
- Limacorporate S.p.A
- Product
- Delta Cup Beater Positioner - Aligner, model # 9057.20.555 Used during implantation of the Delta Acetabular System
- Status
- Completed
- Initiated
- 2017-09-08
- Posted
- not on file
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Vendor change control
- Action
- The Firm, Lima Corporate has notified the US agents of the recall and asked to check each single set with the affected product codes, identify the items and remove them from the inventory. The US distributors have also been instructed to fill out and sign a response document specifying the quantities returned. For further questions, please call (800) 962-2578.
- Quantity
- 20 units in (US)
- Distribution
- Worldwide Distribution - US Distribution and to the countries of : Australia, Austria, Belgium, Brazil, Czech Republic, Germany, Italy, New Zealand, Poland, Russia, Slovakia, Slovenia, Spain, South Africa, Switzerland, Turkey, UK and Germany
- Lot, serial or model codes
- Lot # 15AG0HJ, 15AG0HQ, 15AG0UY, 15AG00P, 15AG040, 15AG08Y, 14AG243, 15AG00Q, 15AG0UZ, 15AG0V0, 15AG0HN, 16AG02J
- 510(k) numbers
- ["K141395"]
- PMA numbers
- not on file
- Product code
- LXH
- Firm FEI
- 3008021110
- Firm city
- San Daniele del Friuli
- Firm state
- not on file
- Firm country
- Italy
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28