BONE SCREWS · recalls, adverse events, clearances

Adverse-event reports (MAUDE)

Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.

No adverse-event reports are linked to this device.

Recall history

Initiated	Recall #	Class	Status	Reason	Quantity	Link basis
2021-10-01	Z-0159-2022	Class II	Terminated	There is a potential that the length of bone screws identified on labeling may not correspond to the actual length of the screw included.Distribution: Worldwide distribution - US Nationwide distribution in the states of CA, FL, MO, KS, CO, TX, KS, IL, PA, NY, NC, MI, MA, OK and the countries of Austria, Croatia, Germany, Ireland, Italy, Japan, Korea, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden.	151 units	clearance family
2021-10-01	Z-0160-2022	Class II	Terminated	There is a potential that the length of bone screws identified on labeling may not correspond to the actual length of the screw included.Distribution: Worldwide distribution - US Nationwide distribution in the states of CA, FL, MO, KS, CO, TX, KS, IL, PA, NY, NC, MI, MA, OK and the countries of Austria, Croatia, Germany, Ireland, Italy, Japan, Korea, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden.	200 units	clearance family

Regulatory clearances

510(k)K172456Substantially equivalent (SESE) · 2018-01-04clearance family

Predicate lineage

K172456

Cited as predicate by: K181491, K183042, K201905

Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.

Manufacturer compliance record

None in the loaded window.

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