Z-0941-2018Class II

Accolade and Restoration hip product; Catalog Number: 6021-0030, 6276-1-127, 6276-5-216, 6020-2530...

Name: Z-0941-2018 Accolade and Restoration hip product; Catalog Number: 6021-0030, 6276-1-127, 6276-5-216, 6020-2530...
Creator: Howmedica Osteonics Corp.
Published: 2017-07-21
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2017-07-21 / Terminated / root cause: manufacturing process

FDA source

Howmedica Osteonics Corp. began a recall of Accolade and Restoration hip product; Catalog Number: 6021-0030, 6276-1-127, 6276-5-216, 6020-2530, 6020-4535, 6021-0740, 6021-0230, and 6021-4535 on 2017-07-21. FDA classified it as Class II and gives the reason as "Inner and outer sterile barriers not fully sealed". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0941-2018
Classification: Class II
Status: Terminated
Initiated: 2017-07-21
Posted: 2018-03-09
Terminated: 2020-03-12
Recalling firm: Howmedica Osteonics Corp
Product: Accolade and Restoration hip product; Catalog Number: 6021-0030, 6276-1-127, 6276-5-216, 6020-2530, 6020-4535, 6021-0740, 6021-0230, and 6021-4535
Product code: LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Reason for recall: Inner and outer sterile barriers not fully sealed.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Recall notices were sent to customers with a request to return all affected product.
Quantity in commerce: 255
Distribution: Distributed in ten (10) states: AR, DE, FL, IL, IN, MI, NJ, OH, TN, and TX; and Canada, Sweden, United Kingdom, France, Spain, Italy, Japan, Romania, Colombia, Netherlands, and Australia.
Product codes and lots: Lot: 55624702, 55709001, 55709002, 55709003, 55959003, 55967305, 56011203, 56011205, 56011301, 56019501, and 56109304

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0941-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0940-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-09
Z-0941-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-09

Product code LPH

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)