Stryker, Gamma K-Wire 3.2x450 mm, UNS-Thread Product Usage: Intended for the temporary stabilization of bone segments or
FDA device recall Z-0870-2016 · posted 2016-02-25 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
- Action taken
- Stryker Orthopaedics sent an Urgent Medical Device Removal letter and Customer Response forms dated January 21, 2016 through UPS. The letter identified the affected product, problem, actions to be taken including forwarding notice if applicable, returning all affected products and completing and returning the Customer Response form to Stericycle.by the instructions provided.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- HSB
- Quantity affected
- 147,838 units in total
- Distribution
- US Nationwide Distribution
- Date initiated
- 2016-01-21
- Date posted
- 2016-02-25
- Date terminated
- 2017-06-08
- Location
- Mahwah, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GAMMA3 AND T2 RECON TARGETING DEVICES (K123401) | Stryker Trauma AG | 2013-01-23 |