Hoffman II compact Sterile Wrist Kit is used in the stabilization of open and unstable fractures.
This recall has been terminated (originally issued September 16, 2008).
- Recall Initiated
- August 17, 2005
- Posted
- September 16, 2008
- Terminated
- September 24, 2008
- Recall Number
- Z-2080-2008
- Quantity
- 105 units
- Firm Location
- Mahwah, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
Stryker Orthopaedics became aware that the pin of the Hoffmann II Compact External Fixation System may jam into the Soft Tissue protector.
Distribution
The product was distributed to 23 Stryker Branches, 25 hospitals and 1 government hospital nationwide
Lot / Code Info
Catalog Number: 4940-9-810: Lot Codes: H11883, H13813, H17174, H18891, K01047, K03042, K05896.
Root Cause
Device Design
Action Taken
Letters were sent to Stryker branches and hospitals on August 17, 2005. If you have questions concerning this recall, contact Rita Intorrella at 201-831-5825 or Katherine Collins at 201-831-5025.
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