Recall record at a glance
| Official record | Z-2397-2016 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Zimmer Biomet Spine, Inc. |
| Report date | Aug 17, 2016 |
| Recall initiation date | Jun 30, 2016 |
| Quantity | 5 |
| Location | Broomfield, CO, United States |
Official product description
Zyston Transform Instrument Case. Model Number PCR8200-2101. Device labeled sterile.
Why the product was recalled
Zimmer Bioment Spine, Inc. announces a voluntary field action for the Zyston Transform Instrument Case and Zyston Transform Implant Kit because the locking mechanism on the implant is not functioning as intended.
Distribution information
Nationwide to PA, TX, TN, NV, VA, WV, and KY. No Canadian, other foreign, VA/gov/military consignees.
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: Other.
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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