Zimmer Gmbh: Medical Device Recall in 2015 - (Recall #: Z-1133-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

Metasul Femoral Head - A modular head component is used in conjunction with a femoral stem component for replacement of the proximal femur in total hip arthroplasty.

Product Classification:

Class II

Date Initiated: December 17, 2014

Date Posted: March 4, 2015

Recall Number: Z-1133-2015

Event ID: 70401

Reason for Recall:

Potential compromise of the inner sterile tray. If a compromised tray is detected, a delay in surgery may result. If undetected breach in both the inner and outer trays were to occur, and there is contamination present, a periprosthetic infection is possible, which could lead to revision.

Status: Terminated

Product Quantity: 30

Code Information:

Item numbers: 19.32.05; 19.32.06; 19.32.08; Lot #'s: 2560585, 2553420, 2556039, 2560586, 2563398

Distribution Pattern:

Domestic: AK, AL, AR, AZ, CA, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MS, MA, MD, ME, MI, MN, MO, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY International: Canada, Japan

Voluntary or Mandated:

Voluntary: Firm initiated