Recall record at a glance
| Official record | Z-2399-2012 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Biomet, Inc. |
| Report date | Sep 26, 2012 |
| Recall initiation date | Aug 14, 2012 |
| Quantity | 62 |
| Location | Warsaw, IN, United States |
Official product description
JUGGERKNOT IN¿GUIDE PUNCH, 2.9MM. The JuggerKnot 2.9mm In-Guide Punch is intended to be used to prepare a 2.9mm hole into bone in which the JuggerKnot 2.9mm Suture Anchor is to be placed. The JuggerKnot 2.9mm Suture Anchor is intended to be used to attach soft tissue to bone.
Why the product was recalled
Investigation found that the current design of the product allows the press-fit of the knob/shaft interface to be overcome by the impaction force of a mallet, causing the knob to potentially unfasten and slide down the shaft.
Distribution information
Nationwide Distribution-including the states of WA, IN, AK, PA, GA, SD, KS, NY, VA, AR, AL, OH, WI, MA, and CA.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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