Teflon Tube, sterile T2 Humerus System Stryker Trauma GmbH Prof Kuntscher Str 1-5 24232 Sconkidrchen, Germany distribute
FDA device recall Z-0849-2014 · posted 2014-01-28 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- Stryker became aware during laboratory testing that there is a potential that the seal integrity of the outer pouch (sterile barrier) may be compromised for certain lots of the product Teflon Tube, sterile.
- Action taken
- The firm, Stryker, sent an "URGENT MEDICAL DEVICE REMOVAL" letter dated December 17, 2013 to its customers via e-mail. Preliminary notification letters and Product Accountability Forms were sent via FedEx on November 15, 2013 with return receipt to the Stryker locations. Notification and Product Accountability Forms were sent 12/18/2013 via Fed Ex with return receipt. Updated letters were sent via Fed Ex on 12/19/2013 with return receipt. The letter described the product, problem and actions to be taken. The customers were instructed to quarantine affected devices in local inventory as well as retrieve any devices located in hospitals; inform users of the Medical Device Removal and pass this to all those individuals who need to be aware within your organization; return all affected products available to your location to: Stryker Osteosynthesis, c/o Colleen O'Meara, Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ, 07430, REF: PFA#2013-168 or contact Stryker customer service and refer to PFA #2013-166 for returning the product to us; complete and return the enclosed Business Reply Form and fax a copy to: 1-865-251-3635 or email a copy to Recall Coordinator at aminah.crawford@stryker.com, and keep a copy of the completed and executed Business Reply form for your records. If you have any further questions, contact Manager, Regulatory Compliance at 1-201-972-2100 or email: colleen.omeara@stryker.com.
- Root cause
- Process design
- Status
- Terminated
- Product code
- HSB
- Quantity affected
- 34 units
- Distribution
- US Distribution in states of: GA, IL, KY, MI, MO, NJ, TN, UT and VA.
- Date initiated
- 2013-11-07
- Date posted
- 2014-01-28
- Date terminated
- 2015-03-31
- Location
- Mahwah, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| T2 PROXIMAL HUMERAL NAIL (K042396) | Howmedica Osteonics Corp. | 2004-10-08 |