Zimmer Gmbh: Medical Device Recall in 2016 - (Recall #: Z-2292-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

Avenir M¿ller Stem 4 Standard Avenir M¿ller Stem 6 Lateral Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Intended Use: " Advanced wear of the joint due to degenerative, post-traumatic or rheumatic diseases. " Failed previous hip surgery including joint reconstruction (osteotomy), arthrodesis, hemiarthroplasty or total hip replacement (THR). " Acute traumatic fracture of the femoral head or neck " Avascular necrosis of the femoral head. " Avenir Moller Stems are for cementless use only.

Product Classification:

Class II

Date Initiated: June 30, 2016

Date Posted: August 3, 2016

Recall Number: Z-2292-2016

Event ID: 74693

Reason for Recall:

Product mix-up. The Avenir M¿ller Stem 6 lateral uncemented might be placed in the packaging of the Avenir M¿ller Stem 4 standard uncemented and vice versa. Potential for delay in surgery, and/or potential for use of incorrect implant which may in turn lead dismetry in patient and possibly the need for revision.

Status: Terminated

Product Quantity: 2

Code Information:

Item Name: Avenir M¿ller Stem 4 Standard Item Number: 01.06010.004 Lot Number: 4022860 Item Name: Avenir M¿ller Stem 6 Lateral Item Number: 01.06010.106 Lot Number: 4023094

Distribution Pattern:

Nationwide Distribution to OH and NM

Voluntary or Mandated:

Voluntary: Firm initiated