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BMP COMPRESSION HIP SCREW
Biomet Orthopedics, LLC · Model 197158 · UDI-DI 00880304275331
JDO
Prescription
1
510(k) clearances
286
Adverse events
8
Recalls
58
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2020-01-07 | Zimmer Biomet, Inc. | Potential increase in fracture rate was detected during internal testing, in addition to potential discoloration inside the inner pouch of the packaging. |
| 2018-08-09 | Biomet UK Ltd. | 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 |
| 2018-08-09 | Biomet UK Ltd. | 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 |
| 2018-08-09 | Biomet UK Ltd. | 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 |
| 2018-08-09 | Biomet UK Ltd. | 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 |
| 2017-12-21 | Howmedica Osteonics Corp. | From March 2007 to October 2014, product did not contain updated instructions for use (IFU) to clarify the function of locking mechanism and warnings related to the locking screw. |
| 2016-06-10 | Biomet, Inc. | The screw may fracture at the junction of the shaft and the head during implantation. The patient may retain a foreign body if the fractured screw cannot be removed. Soft tissue ir |
| 2013-10-11 | Zimmer, Inc. | Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determ |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.