Z-2215-2012Class II

00-4309-029-01 - Trabecular Metal Reverse Shoulder Liner 36 mm 65 Neck Angle Per surgical technique...

Name: Z-2215-2012 00-4309-029-01 - Trabecular Metal Reverse Shoulder Liner 36 mm 65 Neck Angle Per surgical technique...
Creator: Zimmer, Inc.
Published: 2012-07-18
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2012-07-18 / Terminated / root cause: design

FDA source

Zimmer, Inc. began a recall of 00-4309-029-01 - Trabecular Metal Reverse Shoulder Liner 36 mm 65 Neck Angle Per surgical technique 97-4309-003-00 Revision 4: "Complete Poly Liner insertion... on 2012-07-18. FDA classified it as Class II and gives the reason as "Lot specific Trabecular Metal (TM) Reverse Shoulder Liner Impactors are being recalled due to reports of alignment peg fractures. All lots of TM Reverse Shoulder Liner Impactors manufactured from 455 stainless steel are...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2215-2012
Classification: Class II
Status: Terminated
Initiated: 2012-07-18
Posted: 2012-08-16
Terminated: 2014-04-17
Recalling firm: Zimmer GmbH
Product: 00-4309-029-01 - Trabecular Metal Reverse Shoulder Liner 36 mm 65 Neck Angle Per surgical technique 97-4309-003-00 Revision 4: "Complete Poly Liner insertion by snapping the appropriate 60 (Standard) or 65 (Retentive) Poly Liner Impactor to the Poly Liner Impactor Handle. Then, place the Poly Liner Impactor on the Poly Liner articular surface and forcefully strike the Poly Liner Handle with a mallet."
Product code: KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
Reason for recall: Lot specific Trabecular Metal (TM) Reverse Shoulder Liner Impactors are being recalled due to reports of alignment peg fractures. All lots of TM Reverse Shoulder Liner Impactors manufactured from 455 stainless steel are being retrieved, as all reported fractured instruments were manufactured with this material. The TM Reverse Shoulder Liner Impactor units that were manufactured with 13-8 stain
Root cause tag: design
FDA root cause: Device Design
Action: Zimmmer sent an Urgent Medical Device Recall letter dated July 18, 2012, to all affected customers. The letter identified the product, the problem, and thea action to be taken by the customer. Customers were instructed to inspect all TM Reverse instrument sets for affected lot(s)(instruments. If affected product was found customers were instructed to immediately place an order to backfill the identified product with Customer Service. If an instrument was was further distributed customers were to provide a copy of the Notice to ensure their customers were aware of the removal. Customers were also instructed to provide a list of all hospitals that currently use the affected product. For questions customers were instructed to call 800-348-2759. For questions regarding this recall call 574-371-1689.
Quantity in commerce: 212 (179 USA)
Distribution: Worldwide Distribution - USA (nationwide) and internationally to Germany, Belgium, Denmark, Finland, France, Italy, Netherlands, Spain, Sweden, Switzerland, and the United Kingdom.
Product codes and lots: Part 00-4309-029-01: Lot 60535162, 60545338, 60576488, 60605855, 60637022, 60689253, 60772974, 60875277, 60918060, 60989817, 61011689, 61024161, and 61051024.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2215-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2212-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-22	2012-08-16
Z-2213-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-22	2012-08-16
Z-2214-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-22	2012-08-16
Z-2215-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-22	2012-08-16

Product code KWA

K060704Class IIZimmer Trabecular Metal Reverse Shoulder System, Sizes 8Mm and 10MmZimmer, Inc. / cleared 2006-05-19

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)