Recalls / —
—#151063
Product
Synthes 0.76 mm Drill Bit/Stryker J-Latch/with 5mm Stop/44.5 mm Non-Sterile
- FDA product code
- HWE — Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
- Device class
- Class 1
- Medical specialty
- General, Plastic Surgery
- 510(k) numbers
- K043310
- Affected lot / code info
- Model/Catalog # 316.15 Lot/Serial Number U172728
Why it was recalled
Package may be incorrectly labeled as containing 0.76 mm Drill Bit, but in fact contain a 1.1 mm diameter Drill Bit.
Root cause (FDA determination)
Under Investigation by firm
Action the firm took
DePuy Synthes sent an Urgent Notice to customers affected by the recall to inform them of the potential impacts, and actions to be taken for the return of the identified units.
Recalling firm
- Firm
- Synthes (USA) Products LLC
- Address
- 1301 Goshen Pkwy, West Chester, Pennsylvania 19380-5986
Distribution
- Distribution pattern
- Distributed Nationwide
Timeline
- Recall initiated
- 2016-11-01
- Posted by FDA
- 2016-12-01
- Terminated
- 2017-06-01
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #151063. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.