Recall record at a glance
| Official record | Z-3263-2018 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Biomet UK Ltd. |
| Report date | Oct 3, 2018 |
| Recall initiation date | Aug 9, 2018 |
| Quantity | 44 units |
| Location | Bridgend, United Kingdom |
Official product description
HipLOC Hip Fracture Fixation System-Hiploc System 135 Plate 38 mm Barrel 4 Hole Plate Item Number: 2110-135-004 Product Usage: The HipLOC Compression Hip Screw may be used primarily for fixation of bone fractures. Specific indications include open reduction and internal fixation of a wide variety of fractures of the proximal femur: intracapsular fractures, intertrochanteric fractures and subtrochanteric fractures
Why the product was recalled
HipLOC System Plate Barrel due to an undersized bore on the HipLOC plate barrel, can result in the lag screw not fitting through the barrel
Distribution information
US Nationwide in the states of AZ, MO, NJ and NM
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
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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