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U.S. v. AN ART. OF DEVICE, 1,217 CARDBOARD BOXES

No. K 84-502.

607 F.Supp. 990 (1985)

UNITED STATES of America, Plaintiff, v. AN ARTICLE OF DEVICE CONSISTING OF 1,217 CARDBOARD BOXES, more or less, each containing an individually packaged unit in a tube packaged in a blister-pack with an insert labeled in part as follows: (box) "*** stryker *** A0931660404261C *** B311001c ***", (tube) "stryker Shoulder 130-10 Dacron * Ligament Prosthesis ***", Defendant.

United States District Court, W.D. Michigan, S.D.

April 2, 1985.

Attorney(s) appearing for the Case

Thomas Martin, Asst. U.S. Atty., Grand Rapids, Mich., Mark A. Heller, Assoc. Chief Counsel for Enforcement, Food & Drug Admin., Rockville, Md., for plaintiff.

Grant Gruel, Grand Rapids, Mich., for defendant.

OPINION

ENSLEN, District Judge.

This action was filed on November 20, 1984 against a prosthetic shoulder ligament device, manufactured by Meadox Medicals, Inc., and distributed by Stryker Corporation. The device is used in the surgical repair of third-degree, and sometimes second-degree, acromioclavicular separation, a severe dislocation of the joint which stabilizes the clavical (collarbone) and scapula (shoulder blade). See, 1A Gordy & Gray...

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