Z-1092-2014Class II

00434811113, REF I4348-111-13 Zimmer Trabecular Metal Shoulder Humeral Stem 48 Degrees 11 mm Stem Diameter...

Name: Z-1092-2014 00434811113, REF I4348-111-13 Zimmer Trabecular Metal Shoulder Humeral Stem 48 Degrees 11 mm Stem Diameter...
Creator: Zimmer, Inc.
Published: 2014-01-10
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2014-01-10 / Terminated / root cause: manufacturing process

FDA source

Zimmer, Inc. began a recall of 00434811113, REF I4348-111-13 Zimmer Trabecular Metal Shoulder Humeral Stem 48 Degrees 11 mm Stem Diameter 130 mm Stem Length Trabecular Metal Humeral Stem 48... on 2014-01-10. FDA classified it as Class II and gives the reason as "This single manufacturing lot has the potential for the bond strength between the Trabecular Metal material and substrate to be below the minimum required specification. Testing found bond strength approximately 80% of...". 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-1092-2014
Classification: Class II
Status: Terminated
Initiated: 2014-01-10
Posted: 2014-02-26
Terminated: 2014-09-11
Recalling firm: Zimmer GmbH
Product: 00434811113, REF I4348-111-13 Zimmer Trabecular Metal Shoulder Humeral Stem 48 Degrees 11 mm Stem Diameter 130 mm Stem Length Trabecular Metal Humeral Stem 48 Degree 11mm x 130mm, Sterile, QTY 1, Rx Product Usage: Zimmer Trabecular Metal TM Humeral Stem is a shoulder prosthetic replacement device that is indicated for the treatment of severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint as well as humeral fractures. The humeral stem uses. Trabecular Metal around the proximal part of the stem for biological ingrowth.
Product code: KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
Reason for recall: This single manufacturing lot has the potential for the bond strength between the Trabecular Metal material and substrate to be below the minimum required specification. Testing found bond strength approximately 80% of the minimum required by specification in one of the three zones of the Trabecular Metal. The other two zones exceeded the minimum specification.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Zimmer sent an Urgent Medical Device Recall dated January 10, 2014 to distributors via electronic mail. The hospital/surgeon that has implanted this manufacturing lot will be identified and notified by the distributor. The letter identified the affected product, problem and actions to be taken. Distributors were instructed to locate and remove the affected product in their territory, as well as identifying and notifying the hospital/surgeon that has implanted this manufacturing lot as applicable. The distributor will return on-hand affected products to Zimmer and ensure all of their products are accounted for using the return form provided in the letter. Distributors and hospital consignees are to complete and return the inventory return form and acknowledgement form indicating which hospital/surgeon has implanted the product and to which they have provided notice to. Email a copy of the completed return form to [email protected] outside of the United States will occur approximately two weeks after the United States communications. For questions call 1-877-946-2761
Quantity in commerce: 10 units
Distribution: Distribution USA in the state of Illinois.
Product codes and lots: lot 62267250

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1092-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1092-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-05	2014-02-25

Product code KWT

K041549Class IIZimmer Trabecular Metal Humeral StemZimmer, Inc. / cleared 2004-09-01

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)