Z-2426-2011

Ringloc + Acetabular Shell limited hole finned 56 mm Size 24 porous coat, for uncemented use, sterile, REF...

Name: Z-2426-2011 Ringloc + Acetabular Shell limited hole finned 56 mm Size 24 porous coat, for uncemented use, sterile, REF...
Creator: Biomet, Inc.
Published: 2011-04-14
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2011-04-14 / Terminated / root cause: manufacturing process

FDA source

Biomet, Inc. began a recall of Ringloc + Acetabular Shell limited hole finned 56 mm Size 24 porous coat, for uncemented use, sterile, REF 16-104156, Biomet Orthopedics, Warsaw, IN. Intended... on 2011-04-14. The reason FDA records is "The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. If the locking ring is incorrectly assembled in the acetabular shell...". 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-2426-2011
Status: Terminated
Initiated: 2011-04-14
Posted: 2011-06-08
Terminated: 2011-09-16
Recalling firm: Zimmer GmbH
Product: Ringloc + Acetabular Shell limited hole finned 56 mm Size 24 porous coat, for uncemented use, sterile, REF 16-104156, Biomet Orthopedics, Warsaw, IN. Intended Use: The Porous Plasma Spray (PPS) Ringloc Acetabular System is intended to replace the natural acetabulum damaged by disease, trauma or revision of previous arthroplasty. Indications For Use: 1 . Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis 3. Correction of functional deformity 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed.
Product code: KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
Reason for recall: The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. If the locking ring is incorrectly assembled in the acetabular shell, the liner cannot be completely seated in the shell.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Biomet Orthopedics sent an URGENT MEDICAL DEVICE RECALL NOTICE DATED April 14, 2011, to all affected customers. The notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to: Immediately locate and remove the affected product. Follow the instructions on the enclosed "FAX Back Response Form" and fax a copy of the Response Form to 574-372-1683 prior to return of product. Customers were to confirm receipt of the notice by calling 800-348-9500, ext 3755 or 3756. For any questions regarding this recall call 574-371-3755 or 574-371-3756.
Quantity in commerce: 146
Distribution: Worldwide Distribution - USA (nationwide) and the countries of Australia, Netherlands and Japan.
Product codes and lots: Lot numbers M048180, M061180, M061190, M276160, M276170, M276180, M299730, M383260, M383290, M383300, M874150, M903110, M903160, M903180, M903190, M903200, M903220, M903230, and M048200.

Product code KWA

K093235Class IIIRingloc + Hybrid Acetabular SystemBiomet, Inc. / cleared 2010-04-30

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)