Recall Z-0884-2016— Stryker Howmedica Osteonics Corp.
Class II · Terminated
Class II FDA medical device recall by Stryker Howmedica Osteonics Corp., initiated 2016-01-21, terminated 2017-06-08. FDA's recall record names no specific 510(k) clearance for this event. Product: Stryker, T2 K-Wire, 3.2x400mm, CoCr, Recon Product Usage: Intended for the temporary stabilization of bone segments or fragments.. Reason: During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased..
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-01-21
- Terminated
- 2017-06-08
- Firm location
- Mahwah, NJ, United States
Product description
Stryker, T2 K-Wire, 3.2x400mm, CoCr, Recon Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Reason for recall
During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
Data sourced from openFDA. This site is unofficial and independent of the FDA.