Recall record at a glance
| Official record | Z-0320-2020 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Zimmer Biomet, Inc. |
| Report date | Nov 13, 2019 |
| Recall initiation date | Oct 10, 2019 |
| Quantity | 5,459,583 total devices |
| Location | Warsaw, IN, United States |
Official product description
Fitmore Hip Stem, hip prosthesis, various sizes, Item Nos. 0100551102 0100551103 0100551104 0100551105 0100551106 0100551107 0100551108 0100551109 0100551110 0100551111 0100551112 0100551113 0100551114 0100551201 0100551202 0100551203 0100551204 0100551205 0100551206 0100551207 0100551208 0100551209 0100551210 0100551211 0100551212 0100551213 0100551214 0100551301 0100551302 0100551303 0100551304 0100551305 0100551306 0100551307 0100551308 0100551309 0100551310 0100551311 0100551312 0100551313 0100551314 0100551401 0100551402 0100551403 0100551404 0100551405 0100551406 0100551407 0100551408 0100551409 0100551410 0100551411 0100551412 0100551413 0100551414
Why the product was recalled
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Distribution information
Distributed nationwide.
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
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