Reported Jun 1, 2016 · Terminated
3.2 mm Three-fluted drill bit, sterile, Catalog ID # 03.010.060S Product Usage: Usage: The 3.2 mm Three-fluted Drill…
Synthes (USA) Products LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Synthes (USA) Products LLC · 1301 Goshen Pkwy · West Chester, PA · 19380-5986
Is this the product you have?
3.2 mm Three-fluted drill bitsterileCatalog ID # 03.010.060S
- Product UsageUsage: The 3.2 mm Three-fluted Drill Bits are instruments that
- can be used with the following systemsExpert Lateral Femoral Nail (part number 03.010.060S only), Expert Tibial Nail, Expert Humeral Nailing, Multiloc Humeral Nailing System, Suprapatellar Instrumentation for Expert Tibial Nail, and Adolescent Lateral Femoral Nails (ALFN)
- Lot codes and dates
244 of 244 codes
Catalog ID 03.010.060S Lot # 555880962043246813586764883755598396214366681843876488385575915623567668278077657752557971762402876830470765775355822986247514683563476603805585788624983468419627661528 559423762693366851101766152955942386276953685754676744145616439627975668607047687319563306762797576870563769316456569146302746687339477166045672506631356868733967731690 56820436313569689804077390275692087632542069043777753584570220663319236908328776665457119666334954
- Amount recalled
- 7363 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
The sterile packaging may be compromised. A protective cap is to be secured on the tip of the drill bit. If the protective cap is not secured, the drill bit may puncture the sterile barrier.
This product could cause temporary or reversible health problems — stop using it.
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