Zimmer, Inc.: Zimmer Inc. is initiating a removal of the CPT Modular Stem (item 00-8011-001-00), CPT Stem Petite (item 00-8011-000-05; ) and CPT Femoral Stem 12/14 Neck Taper Extended Offset,(item 00-8114-001-10 ) because devices were packaged in incorrect cartons and distributed internationally and domestically. Zimmer received five complaints of this packaging issue.

Agency Publication Date: October 15, 2012

Affected Products

Product: CPT Modular Stem, Item No. 00-8011-001-00; Lot 61947708. CPT stems are primary cemented femoral hip stems used by surgeons in total hip arthroplasty.

Lot 61947708

Lot Numbers:

61947708

Product: CPT Hip System Femoral Stem Petite, Item No. 00-8011-000-05. CPT stems are primary cemented femoral hip stems used by surgeons in total hip arthroplasty.

Lot 62017554

Lot Numbers:

62017554

Product: CPT Femoral Stem 12/14 Neck Taper Extended Offset,(item 00-8114-001-10. CPT stems are primary cemented femoral hip stems used by surgeons in total hip arthroplasty.

Item 00-8114-001-10, lots 61947699 and 61952551

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 63124

Status: Resolved

Manufacturer: Zimmer, Inc.

Manufactured In: United States

Units Affected: 3 products (59 both units; 20; 59 both lots)

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Sources: FDA iRES · Raw API Response

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Affected Products

Product: CPT Modular Stem, Item No. 00-8011-001-00; Lot 61947708. CPT stems are primary cemented femoral hip stems used by surgeons in total hip arthroplasty.

Lot 61947708

Lot Numbers:

61947708

Product: CPT Hip System Femoral Stem Petite, Item No. 00-8011-000-05. CPT stems are primary cemented femoral hip stems used by surgeons in total hip arthroplasty.

Lot 62017554

Lot Numbers:

62017554

Product: CPT Femoral Stem 12/14 Neck Taper Extended Offset,(item 00-8114-001-10. CPT stems are primary cemented femoral hip stems used by surgeons in total hip arthroplasty.

Item 00-8114-001-10, lots 61947699 and 61952551