Recall record at a glance
| Official record | Z-1954-2016 |
|---|---|
| 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
REV. SHELL LINER 0D 28X48 00700504828 REV. SHELL LINER 10D 28X50 00701005028 REV. SHELL LINER 10D 28X52 00701005228 REV. SHELL LINER 10D 28X54 00701005428 REV. SHELL LINER 10D 28X56 00701005628 REV. SHELL LINER 10D 28X58 00701005828 REV. SHELL LINER 10D 28X60 00701006028 REV. SHELL LINER 10D 28X62 00701006228 REV. SHELL LINE 10D 28X66 00701006628 REV. SHELL LINER 20D 28X48 00702004828 REV. SHELL LINER 20D 28X50 00702005028 REV. SHELL LINER 20D 28X52 00702005228 REV. SHELL LINER 20D 28X54 00702005428 REV. SHELL LINER 20D 28X56 00702005628 REV. SHELL LINER 20D 28X60 00702006028 REV. SHELL LINER 20D 28X62 00702006228 REV. SHELL LINER 20D 28X66 00702006628
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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