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Restoration

Howmedica Osteonics Corp. · Model 6276-8-417 · UDI-DI 07613154254774

MAY KWZ LPH LWJ KWL MEH LZO JDI KWY MBL Prescription

510(k) clearances

499

Adverse events

Recalls

Facilities

Description

Modular Hip System

Recalls

Date	Firm	Reason
2016-01-21	Stryker Howmedica Osteonics Corp.	During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
2016-01-21	Stryker Howmedica Osteonics Corp.	During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
2016-01-21	Stryker Howmedica Osteonics Corp.	During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
2016-01-21	Stryker Howmedica Osteonics Corp.	During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
2016-01-21	Stryker Howmedica Osteonics Corp.	During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
2016-01-21	Stryker Howmedica Osteonics Corp.	During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
2016-01-21	Stryker Howmedica Osteonics Corp.	During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
2016-01-21	Stryker Howmedica Osteonics Corp.	During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
2016-01-21	Stryker Howmedica Osteonics Corp.	During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
2016-01-21	Stryker Howmedica Osteonics Corp.	During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.