Zimmer Biomet, Inc.: M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed within the polyethylene bag containing the implant. The black residue is a combination of the titanium plasma spray used to create the porous surface of the implant and polyethylene bag containing the implant. The recalling firm states the residue is biocompatible. Risks include delay of sur

Agency Publication Date: July 5, 2018

Affected Products

Product: Zimmer M/L Taper Hip Prosthesis Plasma Sprayed, Size 4 Extended Offset, 00-7711-004-40

61967700 62386066 62386068 62410987 62416627 62445412 62450669 62458974 62472166 62484291 62503192 62515309 62594187 62601210 62615697 62622678 62636747 62665742 62681670 62740032 62797379 62797380 62882393 62917816 62114291R 77003795R

Product: Zimmer¿ M/L Taper Hip Prosthesis Plasma Sprayed, Size 4 Standard Offset; 00-7711-004-10

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Product: Zimmer¿ M/L Taper Hip Prosthesis With Kinectiv¿ Technology Cementless, Size 5; 00-7713-005-00

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Product: Zimmer¿ M/L Taper Hip Prosthesis With Kinectiv¿ Technology Cementless, Size 6; 00-7713-006-00

62044925 62571340 62831345 62869740 62953032 63068885 63081184 63089967

Product: Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 10; 00-7713-010-00

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Product: Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 11; 00-7713-011-00

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Product: Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 12.5; 00-7713-012-00

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Product: Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 13.5; 00-7713-013-00

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Product: Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 15; 00-7713-015-00

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Product: Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 16.25; 00-7713-016-00

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Product: Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 17.5; 00-7713-017-00

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Product: Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 20; 00-7713-020-00

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Product: Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 22.5; 00-7713-022-00

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Product: Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 7.5; 00-7713-007-00

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Product: Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 9; 00-7713-009-00

62350575 62647167 62787292 63044896 63044897 63068905 63076554 63120523 63161387 63174034

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 80188

Status: Resolved

Manufacturer: Zimmer Biomet, Inc.

Manufactured In: United States

Units Affected: 15 products (280; 294; 227; 96; 24; 132; 84; 510; 1024; 665; 182; 138; 101; 58; 116)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

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Affected Products