Recall record at a glance
| Official record | Z-1953-2016 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Zimmer Trabecular Metal Technology, Inc. |
| Report date | Jun 22, 2016 |
| Recall initiation date | Apr 15, 2016 |
| Quantity | 19,884 total |
| Location | Parsippany, NJ, United States |
Official product description
TM MONO TIB STR GRN SZ 5 - 00588606510 TM MONO TIB STR GRN SZ 5 12MM - 00588606512 TM MONO TIB STR GRN SZ 5 14MM - 00588606514 TM MONO TIB STR GRN SZ 5 17MM - 00588606517 TM MONO TIB STR GRN SZ 6 10MM - 00588606610 TM MONO TIB STR GRN SZ 6 12MM - 00588606612 TM MONO TIB STR GRN SZ 6 14MM - 00588606614 TM MONO TIB STR GRN SZ 6 17MM - 00588606617 TM MONO TIB STR BLUE SZ 7 10MM - 00588606710 TM MONO TIB STR BLUE SZ 7 12MM - 00588606712 TM MONO TIB STR BLUE SZ 7 14MM - 00588606714 TM MONO TIB STR BLUE SZ 7 17MM - 00588606717 TM MONO TIB STR GRN SZ 5 10MM - 00588607510 TM MONO TIB STR GRN SZ 5 12MM - 00588607512 TM MONO TIB STR GRN SZ 5 14MM - 00588607514 TM MONO TIB STR GRN SZ 5 17MM - 00588607517
Why the product was recalled
Zimmer Biomet is initiating a recall of specific lots of foil pouched, sterile Trabecular Metal implants that were manufactured between April 2011 and October 2012. The foil pouches are part of a dual barrier system to provide sterile integrity.
Distribution information
Nationwide and Foreign.
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: Letter.
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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