Z-0068-2018Class II

Delta Cup Beater Positioner - Aligner, model # 9057.20.555 Used during implantation of the Delta Acetabular...

Name: Z-0068-2018 Delta Cup Beater Positioner - Aligner, model # 9057.20.555 Used during implantation of the Delta Acetabular...
Creator: Limacorporate S.p.A
Published: 2017-09-08
License: https://open.fda.gov/license/

Limacorporate S.p.A. / initiated 2017-09-08 / Completed / root cause: supplier

FDA source

Limacorporate S.p.A began a recall of Delta Cup Beater Positioner - Aligner, model # 9057.20.555 Used during implantation of the Delta Acetabular System on 2017-09-08. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as supplier.

Recall record

Recall number: Z-0068-2018
Classification: Class II
Status: Completed
Initiated: 2017-09-08
Posted: 2017-11-06
Recalling firm: Limacorporate S.p.A.
Product: Delta Cup Beater Positioner - Aligner, model # 9057.20.555 Used during implantation of the Delta Acetabular System
Product code: LXH Orthopedic Manual Surgical Instrument
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.
Root cause tag: supplier
FDA 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 in commerce: 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
Product codes and lots: Lot # 15AG0HJ, 15AG0HQ, 15AG0UY, 15AG00P, 15AG040, 15AG08Y, 14AG243, 15AG00Q, 15AG0UZ, 15AG0V0, 15AG0HN, 16AG02J

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0068-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0068-2018	Class II	Completed	Voluntary: Firm initiated	2017-11-15	2017-11-06

Product code LXH

K141395Class IIDelta Tt Acetabular SystemLima Corporate S.P.A. / cleared 2014-06-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)