Stryker Craniomaxillofacial Issues Nationwide Recall of its Custom Cranial Implant Kits

Stryker Craniomaxillofacial Issues Nationwide Recall of its Custom Cranial Implant Kits; Catalogue Numbers 54-00101, 54-00102, 54-00103 and 54-00104, all lots shipped sterile
Stryker's Craniomaxillofacial (CMF) business unit announced today that the U.S. Food and Drug Administration (FDA) concluded on Dec. 18, 2008 that its recall of the following Stryker CMF's Custom Cranial Implant Kits is a Class I recall, which means the product could pose an imminent hazard to health: Catalogue Numbers 54-00101, 54-00102, 54-00103 and 54-00104, all lots shipped sterile.

The notification relates to a nationwide voluntary recall initiated by Stryker CMF on Oct. 24, 2008 of 322 Custom Cranial Implant Kits after determining that the sterilization validation of the product was not performed according to appropriate standards. Because the company could not assure the sterility of the product, implantation could result in serious health problems including infection (e.g., meningitis), intracranial abscess, wound infection, sepsis, re-operation with revision of cranioplasty, long-term neurological deterioration, additional hospitalization, or long-term intravenous antibiotic treatment. Death can occur if an infection is not diagnosed quickly.

Physicians and hospitals who have product that corresponds to the catalogue numbers listed above should stop implanting the product immediately and return it to Stryker CMF. Stryker recommends that patients who have received these implants be monitored by their physicians for signs of infection for at least six months post-implantation.

Stryker CMF previously notified implanting surgeons, hospital risk managers and its sales representatives of the potential health risks associated with the kits and requested that they return any remaining products to Stryker CMF. Stryker CMF will again notify implanting surgeons, risk managers and its sales representatives of this recall and its potential health risk and request that physicians or hospitals return to Stryker CMF any of this product that has not been implanted.

Physicians and patients with questions related to this issue should contact Stryker CMF at 800-962-6558, Monday – Friday, 8 a.m. to 7 p.m. ET. Patients with questions are encouraged to speak with their surgeon. Any adverse events relating to this product should be reported to Stryker.

Any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

Stryker Corporation is one of the world's leading medical technology companies with the most broadly based range of products in orthopaedics and a significant presence in other medical specialties. For more information about Stryker, please visit www.stryker.com.

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FDA Reports Nationwide Recall of Mislabeled ReliOn Insulin Syringes

The U.S. Food and Drug Administration is notifying health care professionals and patients that Tyco Healthcare Group LP (Covidien) is recalling one lot of ReliOn sterile, single-use, disposable, hypodermic syringes with permanently affixed hypodermic needles due to possible mislabeling. The use of these syringes may lead to patients receiving an overdose of as much as 2.5 times the intended dose, which may lead to hypoglycemia, serious health consequences, and even death.

The recall applies to the following lot number and product information:

-- Lot Number 813900
-- ReliOn 1cc, 31-gauge, 100 units for use with U-100 insulin

Only ReliOn syringes from this lot number and labeled as 100 units for use with U-100 insulin are the subject of the recall.

These syringes are distributed by Can-Am Care Corp and sold only by Wal-Mart at Wal-Mart stores and Sam's Clubs under the ReliOn name. Wal-Mart requests that all users of ReliOn 31-gauge, 1cc syringes return those labeled as 100 units for use with U-100 insulin from Lot Number 813900 to their local Wal-Mart store or Sam's Club pharmacy. Customers will be provided with replacement product.

The FDA urges patients and health care professionals to check their syringe packaging carefully for syringes labeled as 100 units for use with U-100 insulin from Lot Number 813900.

Consumers and health care professionals who suspect they have the recalled product may also contact Covidien at 866-780-5436 or www.relion.com/recall for more information.

ReliOn Insulin Syringes consist of a syringe barrel, a plunger rod, and a hypodermic needle attached to the tip of the syringe.

During the packaging process for this lot, some syringes labeled for use with U-40 insulin were mixed with syringes labeled for use with U-100 insulin, then all packaged individually and in boxes as 100 units for use with U-100 insulin.

The manufacturer has distributed 4,710 boxes in the recalled lot, which equals 471,000 individual syringes. Wal-Mart sold the syringes at Wal-Mart stores and Sam's Clubs from Aug. 1, 2008, until Oct. 8, 2008.

Tyco Healthcare Group LP (Covidien) voluntarily recalled this lot of syringes on Oct. 9, 2008, asking that any units of the affected product be removed from inventory and placed in quarantine. Wal-Mart posted the recall announcement in Wal-Mart stores and Sam's Clubs, as well as on its Web site, and sent letters to more than 16,500 customers notifying them of the recall.

The manufacturer has received one adverse report related to a syringe from this product lot.
Health care professionals and consumers may report serious adverse events (side effects) or product quality problems with the use of this product to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone.

--Online: www.fda.gov/MedWatch/report.htm
--Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
--Fax: (800) FDA-0178
--Phone: (800) FDA-1088

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