Zimmer, Inc.: Medical Device Recall in 2014 - (Recall #: Z-1092-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: January 10, 2014

Date Posted: March 5, 2014

Recall Number: Z-1092-2014

Event ID: 67067

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.

Status: Terminated

Product Quantity: 10 units

Code Information:

lot 62267250

Distribution Pattern:

Distribution USA in the state of Illinois.

Voluntary or Mandated:

Voluntary: Firm initiated